FOLEY CATHETER TEMPERATURE SENSOR— 510(k) K873448

Substantially Equivalent

Respiratory Support Products, Inc.

FDA 510(k) clearance K873448 for FOLEY CATHETER TEMPERATURE SENSOR, Substantially Equivalent on 1987-12-07. Applicant: Respiratory Support Products, Inc..

Clearance details

Applicant: Respiratory Support Products, Inc.
Product code: Code KOD
Advisory panel: Gastroenterology, Urology
Date received: 1987-08-26
Decision date: 1987-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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.