ADVANTAGE— 510(k) K921547

Name: FDA 510(k) clearance K921547
Creator: U.S. Food and Drug Administration
Published: 1993-07-23

Substantially Equivalent

Kci

FDA 510(k) clearance K921547 for ADVANTAGE, Substantially Equivalent on 1993-07-23. Applicant: Kci. Device class: 2.

Clearance details

Applicant: Kci
Product code: Code FMT
Device class: Class 2
Regulation: 21 CFR 880.5130
Advisory panel: General Hospital
Date received: 1992-03-24
Decision date: 1993-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FMT

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K243606 — Babyroo TN3002025-01-17
K230278 — Babyroo TN3002023-05-30
K213551 — Giraffe Omnibed Carestation CS12022-03-02
K201628 — Panda iRes Warmer, Giraffe Warmer2021-02-12
K200319 — HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable2020-04-02

Adverse events under product code FMT

product code FMT

Death: 4
Malfunction: 3,074
Total: 3,078

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.