Gem Premier 4000 with Iqm, Model 4000; Gem Cvp 1 and 2 with Co-Ox; Gem Cvp 3 and 4 Hematocrit

510(k) K061974

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK061974	Date15 Sep 2006Cleared	StatusActive

4 recalls · FDA

3 recalls, same reason
- Terminated Z-2805-2011 FDA Unclassified (pre-2012) initiated 31 May 2011 on shared 510(k) K061974
- Terminated Z-2806-2011 FDA Unclassified (pre-2012) initiated 31 May 2011 on shared 510(k) K061974
- Terminated Z-2803-2011 FDA Unclassified (pre-2012) initiated 31 May 2011 on shared 510(k) K061974
K+ results on the GEM Premier 4000 are too low when compared to a reference analyzer, with biases exceeding allowable error claim of a 0.5 moUL
- Terminated Z-0778-2007 FDA Unclassified (pre-2012) initiated 27 Mar 2007
Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result

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)

510(k) Number: K061974
FDA Product Code: CHL
Models / Variants: Gem Premier 4000 With Iqm, Model 4000
Gem Cvp 1 And 2 With Co-Ox
Gem Cvp 3 And 4 Hematocrit