COBE DISPOSABLE PRESSURE TRANSDUCER— 510(k) K810637

Clearance details

Applicant

Cobe Laboratories, Inc.

Product code

Code DRS

Device class

Class 2

Regulation

21 CFR 870.2850

Advisory panel

Cardiovascular

Date received

1981-03-10

Decision date

1981-04-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Mchenry, IL, US

• K254074 — TruPress2026-09-10
• K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors2025-03-21
• K221782 — Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes2023-03-17
• K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit2017-11-09
• K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit2017-05-24

• K923272 — COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR1993-05-11
• K900105 — COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC1991-03-22
• K905793 — COBE CENTRY 2 BICART OPTION KIT1991-02-12
• K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT1991-02-11
• K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR1990-12-27

Death

8

Malfunction

776

Total

784

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-0288-2020 — (1) Argon Medical Devices Double Female LL Adapter, Special Adapter to Convert a Male Fitting to Female LL, REF 040183000A, 25/box, Sterile, Rx; and (2) Argon Medical Devices Double Male LL Adapter, Special Adapter to Convert a Female Fitting to Male LL, REF 040184000A, 25/box, Sterile, Rx. The firm name on the labels is Argon Medical Devices, Inc., Athens, TX.Class II·Terminated·Argon Medical Devices, Inc·20181016
• Z-0289-2020 — Argon Medical Devices Double Male LL Adapter, REF 040184800A, bulk, non-sterile. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.Class II·Terminated·Argon Medical Devices, Inc·20181016
• Z-0291-2020 — Argon Medical Devices TRI-JECT, 3 Way IV Administration Organizer without Stopcock, REF 041230001A, 25/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.Class II·Terminated·Argon Medical Devices, Inc·20181016
• Z-0292-2020 — Argon Medical Devices Plugs, Male/Female Luer Lock Plug, REF 041295000A, 50/box, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.Class II·Terminated·Argon Medical Devices, Inc·20181016
• Z-0296-2020 — Argon Medical Devices AHD Luer Lock Cap, REF 501303, Sterile, Rx. The firm name on the label is Argon Medical Devices, Inc., Athens, TX.Class II·Terminated·Argon Medical Devices, Inc·20181016

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K810637.