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Transpac™ 460940421

by ICU Medical, Inc.

Transpac™ 460940421 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K052828 on 17 Feb 2006 and listed in FDA GUDID since 28 Jul 2021 (UDI-DI 00840619061029), active as of 23 Oct 2026. One FDA recall is 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

1 closed

Documents

510(k) K052828

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840619061029 UDI-DI Date28 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK052828 Date17 Feb 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052828 decided 17 Feb 2006 Active
  • FDA GUDID UDI-DI 00840619061029 listed 28 Jul 2021 Listed

Recalls

1 recall · FDA

    • Terminated Z-1071-2019 FDA Class II initiated 27 Nov 2018

    Reports of pressure tubing separation between the sampling port and the high pressure tubing on certain lots of extravascular blood pressure transducers, which could lead to delay in therapy, and in rare circumstances, pressure tubing separations could lead to blood loss, air embolism, or contamination of the fluid path.

Timeline

3 dated events

  1. Cleared FDA 510(k) K052828
  2. Recall initiated FDA recalls Z-1071-2019
  3. Listed FDA GUDID 00840619061029

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Transpac™
Generic name
Invasive blood pressure transducer set
Model / Ref / Catalog
460940421
Primary DI / UDI-DI
00840619061029
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 (K052828)

and 8 more cleared under K052828

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)