Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension Sets

510(k) K112893

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

Recall on shared 510(k) K112893; other models may be affected

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK112893	Date18 Oct 2011Cleared	StatusActive

8 recalls · 5 ongoing · FDA

5 recalls, same reason
- Ongoing Z-0197-2026 FDA Class II initiated 29 Aug 2025 on shared 510(k) K112893
- Ongoing Z-0199-2026 FDA Class II initiated 29 Aug 2025 on shared 510(k) K112893
- Ongoing Z-0191-2026 FDA Class II initiated 29 Aug 2025 on shared 510(k) K112893
- Ongoing Z-0198-2026 FDA Class II initiated 29 Aug 2025 on shared 510(k) K112893
- Ongoing Z-0190-2026 FDA Class II initiated 29 Aug 2025 on shared 510(k) K112893
IV sets may leak.
- Terminated Z-1653-2022 FDA Class I initiated 9 Aug 2022
Firm noted an increase in customer reports of leaks.
- Terminated Z-0099-2014 FDA Class II initiated 4 Sep 2013
The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination.
- Terminated Z-1271-2013 FDA Class II initiated 28 Mar 2013
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

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

1 jurisdiction

United States — FDA 510(k) Active

510(k)