K-1 INFANT TRANSPORT SYSTEM— 510(k) K895550

Substantially Equivalent

K-1 Medical Products, Inc.

FDA 510(k) clearance K895550 for K-1 INFANT TRANSPORT SYSTEM, Substantially Equivalent on 1989-12-07. Applicant: K-1 Medical Products, Inc..

Clearance details

Applicant: K-1 Medical Products, Inc.
Product code: Code FMZ
Advisory panel: General Hospital
Date received: 1989-09-13
Decision date: 1989-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FMZ

product code FMZ

Death: 2
Malfunction: 457
Other: 1
Total: 460

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.