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IMed Products IM68135

by Integrated Medical Systems, Inc.

IMed Products IM68135 is a Class II device made by Integrated Medical Systems, Inc., cleared under FDA 510(k) K030888 on 2 Apr 2003 and listed in FDA GUDID since 22 Apr 2025 (UDI-DI 10853155008387), active as of 23 Oct 2026. 16 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

16 ongoing

This device is named in the recall

Documents

510(k) K030888

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 Number10853155008387 UDI-DI Date22 Apr 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK030888 Date2 Apr 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K030888 decided 2 Apr 2003 Active
  • FDA GUDID UDI-DI 10853155008387 listed 22 Apr 2025 Listed

Recalls

17 recalls · 16 ongoing · FDA

  • 16 recalls, same reason

    • Ongoing Z-0335-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0334-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0339-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0332-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0342-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0337-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0330-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0343-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0341-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0344-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0340-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0338-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0345-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0336-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0331-2025 FDA Class II initiated 9 Oct 2024
    • Ongoing Z-0333-2025 FDA Class II initiated 9 Oct 2024

    A limited number of IV bags have been found to leak during filling.

    • Terminated Z-2260-2016 FDA Class II initiated 23 Jun 2016 on shared 510(k) K030888

    An issue was identified after a redesign of the auto compounding device. The compounder cannot meet the designed accuracy specification when dispensing into bags. After reviewing the initial design of the device, it was determined the dispensing volume validation was not properly done and none of the compounders on the market can meet the stated specifications.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

19 dated events

  1. Recall initiated FDA recalls Z-0343-2025
  2. Recall initiated FDA recalls Z-0341-2025
  3. Recall initiated FDA recalls Z-0344-2025
  4. Recall initiated FDA recalls Z-0340-2025
  5. Recall initiated FDA recalls Z-0338-2025
  6. Recall initiated FDA recalls Z-0345-2025
  7. Recall initiated FDA recalls Z-0336-2025
  8. Recall initiated FDA recalls Z-0331-2025
  9. Recall initiated FDA recalls Z-0333-2025
  10. Listed FDA GUDID 10853155008387

9 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
IMed Products
Generic name
Basic intravenous administration set, noninvasive
Model / Ref / Catalog
IM68135
Primary DI / UDI-DI
10853155008387
510(k) Number
FDA product code
KPE
GMDN term
Basic intravenous administration set, noninvasive
Device class
Class II
Regulation number
880.5025
GUDID distribution status
In Commercial Distribution

Related devices

Category: Basic intravenous administration set, noninvasive

Cleared under the same submission (K030888)

and 8 more cleared under K030888

Similar devices

Other devices filed under FDA product code KPE (Container, I.V.).

Other devices from Integrated Medical Systems, Inc.

See all devices from Integrated Medical Systems, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)