MEDI-THERM (MTA-5900) & DETACHABLE HOSES— 510(k) K912051

Clearance details

Applicant

Gaymar Industries, Inc.

Product code

Code DWJ

Device class

Class 2

Regulation

21 CFR 870.5900

Advisory panel

Cardiovascular

Date received

1991-05-09

Decision date

1991-07-30

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Orchard Park, NY, US

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• K100585 — MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA79002011-01-20
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• K963067 — SOF. PRESS EPC 51 SYSTEM1997-01-28
• K961854 — SPR PLUS II OVERLAY SYSTEM (CL250/CL2121996-08-09

Death

7

Injury

679

Malfunction

17,477

Total

18,163

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-2058-2017 — Medi-Therm Hyper/Hypothermia System, MTA7900Class II·Terminated·Stryker Medical Division of Stryker Corporation·20170329
• Z-0933-2014 — The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling the patient. Accessory YSI 400 series patient probe interfaces between the Medi-Therm and patient to sense patient temperature, which is displayed on the device's control panel. The Medi-Therm device controls output water temperature by mixing hot and cold water using hot and cold solenoid valves under microprocessor control. The device includes a circulating pump, heater and refrigeration system. The Medi-Therm controller, connector hose, blanket/body wrap and patient probe comprise the Medi-Therm Hyper/Hypothermia System.Class II·Terminated·Stryker Medical Division of Stryker Corporation·20131227

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K912051.