CLAVE STOPCOCK— 510(k) K080077

Clearance details

Applicant

Icu Medical, Inc.

Product code

Code FMG

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

2008-01-11

Decision date

2008-02-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Salt Lake City, UT, US

• K242255 — Qitexio® 4-Way Stopcock (QIT014)2025-04-29
• K223499 — Three Way Stop Cock2023-07-21
• K223175 — lntravascular Administration Sets with Stopcock and Manifold2023-03-10
• K211204 — SafePort(TM) Manifold (or Stopcock)2022-09-15
• K210516 — Clicky Cross2022-05-16

• K252130 — LifeShield Infusion Safety Software Suite2026-04-02
• K252006 — OTTO Disinfecting Cap2026-03-27
• K251980 — ClaveQS Bag2026-03-20
• K250616 — Clave Neutral-Displacement Needlefree Connectors2025-06-05
• K242114 — Plum Solo Precision IV Pump2025-04-02

Death

14

Malfunction

3,433

Other

1

Total

3,448

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0212-2021 — NanoClave Stopcock w/NanoClave; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709062112(17)250101(30)50(10)4572842. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.Class II·Terminated·ICU Medical, Inc.·20200706
• Z-0213-2021 — 2 Gang 4-Way NanoClave Stopcock Manifold w/Rotating Luer; 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053172(17)241201(30)50(10)4493459;(01)10887709053172(17)241201(30)50(10)4536673. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.Class II·Terminated·ICU Medical, Inc.·20200706
• Z-0220-2021 — Appx 0.82 ml, 3 Gang 4-Way NanoClave¿ Stopcock Manifold w/Rotating Luer. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709053189(17)241201(30)50(10)4537253;(01)10887709053189(17)250101(30)50(10)4557545. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.Class II·Terminated·ICU Medical, Inc.·20200706
• Z-0250-2021 — Clave Stopcock. 1 unit per pouch, 50 multivac pouches per case. UDI:(01)10887709039916(17)250201(30)50(10)4727496. The ICU Medical Clave Stopcock is a device used to administer or withdraw fluids that flow from a container to a patient's vascular system through a needle or catheter inserted into a vein or artery. This device is a four-way stopcock with an integral CLAVE side-port for closed, needleless access to the patient tubing or other fluid container.Class II·Terminated·ICU Medical, Inc.·20200706

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080077.