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ICU Medical A1085

by ICU Medical, Inc.

ICU Medical A1085 is a Class II device made by ICU Medical, Inc., cleared under FDA 510(k) K100576 on 17 Dec 2010 and listed in FDA GUDID since 16 Apr 2017 (UDI-DI 00887709049499), active as of 22 Oct 2026. 8 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

2 ongoing

This device is named in the recall

Documents

510(k) K100576

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 Number00887709049499 UDI-DI Date16 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100576 Date17 Dec 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100576 decided 17 Dec 2010 Active
  • FDA GUDID UDI-DI 00887709049499 listed 16 Apr 2017 Listed

Recalls

8 recalls · 2 ongoing · FDA

    • Ongoing Z-3160-2026 FDA Class II initiated 12 May 2026

    Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

    • Ongoing Z-1720-2022 FDA Class II initiated 1 Aug 2022

    Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

  • 5 recalls, same reason

    • Terminated Z-0193-2021 FDA Class II initiated 6 Jul 2020
    • Terminated Z-0192-2021 FDA Class II initiated 6 Jul 2020
    • Terminated Z-0197-2021 FDA Class II initiated 6 Jul 2020
    • Terminated Z-0201-2021 FDA Class II initiated 6 Jul 2020
    • Terminated Z-0204-2021 FDA Class II initiated 6 Jul 2020

    Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike.

    • Terminated Z-1916-2020 FDA Class II initiated 4 Oct 2019

    There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.

Timeline

10 dated events

  1. Cleared FDA 510(k) K100576
  2. Listed FDA GUDID 00887709049499
  3. Recall initiated FDA recalls Z-1916-2020
  4. Recall initiated FDA recalls Z-0193-2021
  5. Recall initiated FDA recalls Z-0192-2021
  6. Recall initiated FDA recalls Z-0197-2021
  7. Recall initiated FDA recalls Z-0201-2021
  8. Recall initiated FDA recalls Z-0204-2021
  9. Recall initiated FDA recalls Z-1720-2022
  10. Recall initiated FDA recalls Z-3160-2026

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
Basic intravenous administration set, noninvasive
Model / reference
A1085
Primary DI / UDI-DI
00887709049499
510(k) Number
FDA product code
FPA
GMDN term
Basic intravenous administration set, noninvasive
Device class
Class II
Regulation number
880.5440
GUDID distribution status
In Commercial Distribution

Related devices

Category: Basic intravenous administration set, noninvasive

Cleared under the same submission (K100576)

and 8 more cleared under K100576

Other devices from ICU Medical, Inc.

See all devices from ICU Medical, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)