Skip to content

ICU Medical 46115-71

by ICU Medical, Inc.

ICU Medical 46115-71 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K061573 on 19 Sep 2006 and listed in FDA GUDID since 19 Oct 2021 (UDI-DI 00887709087224), active as of 22 Oct 2026. 100 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

100 closed

Documents

510(k) K061573

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00887709087224 UDI-DI Date19 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK061573 Date19 Sep 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061573 decided 19 Sep 2006 Active
  • FDA GUDID UDI-DI 00887709087224 listed 19 Oct 2021 Listed

Recalls

100 recalls · FDA

  • 100 recalls, same reason

    • Terminated Z-0416-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0535-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0541-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0480-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0454-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0572-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0546-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0504-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0461-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0439-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0450-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0542-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0537-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0492-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0523-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0501-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0502-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0513-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0452-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0460-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0497-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0489-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0511-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0539-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0490-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0506-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0569-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0474-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0494-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0459-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0540-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0509-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0507-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0517-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0447-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0456-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0531-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0426-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0556-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0512-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0499-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0574-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0560-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0434-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0432-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0445-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0451-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0532-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0498-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0522-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0471-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0558-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0505-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0470-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0466-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0528-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0481-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0424-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0421-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0444-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0544-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0438-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0573-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0427-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0423-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0562-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0437-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0521-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0462-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0455-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0549-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0529-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0485-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0543-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0545-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0429-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0555-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0457-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0561-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0495-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0468-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0436-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0524-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0430-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0570-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0538-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0479-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0559-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0453-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0435-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0425-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0518-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0493-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0550-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0496-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0431-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0446-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0469-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0486-2017 FDA Class II initiated 27 Sep 2016
    • Terminated Z-0552-2017 FDA Class II initiated 27 Sep 2016

    ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Timeline

102 dated events

  1. Recall initiated FDA recalls Z-0518-2017
  2. Recall initiated FDA recalls Z-0493-2017
  3. Recall initiated FDA recalls Z-0550-2017
  4. Recall initiated FDA recalls Z-0496-2017
  5. Recall initiated FDA recalls Z-0431-2017
  6. Recall initiated FDA recalls Z-0446-2017
  7. Recall initiated FDA recalls Z-0469-2017
  8. Recall initiated FDA recalls Z-0486-2017
  9. Recall initiated FDA recalls Z-0552-2017
  10. Listed FDA GUDID 00887709087224

92 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ICU Medical
Generic name
Invasive blood pressure transducer set
Model / Ref / Catalog
46115-71
Primary DI / UDI-DI
00887709087224
510(k) Number
FDA product code
DRS
GMDN term
Invasive blood pressure transducer set
Device class
Class II
Regulation number
870.2850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Invasive blood pressure transducer set

Cleared under the same submission (K061573)

and 8 more cleared under K061573

Similar devices in this category

Other devices filed under Invasive blood pressure transducer set.

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)