FOLEY-TEMP— 510(k) K831567

Name: FDA 510(k) clearance K831567
Creator: U.S. Food and Drug Administration
Published: 1983-08-10

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K831567 for FOLEY-TEMP, Substantially Equivalent on 1983-08-10. Applicant: Mallinckrodt Critical Care. Device class: 2.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1983-05-16
Decision date: 1983-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K880343 — BURNEY GALLBLADDER CATHETER KIT1989-05-01
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K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE1988-01-29
K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR1988-01-06
K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)1987-11-06

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.