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Infant Incubator

by Air-Shields, Inc.

510(k) K780472

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK780472 Date19 Apr 1978ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FMZ
Device Class
Class II
Regulation
21 CFR Part 880.5400
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Infant Incubator is a device used to provide a controlled environment for infants, with features for humidifying filtered inlet air prior to introduction into the air circulation path. It is designed to maintain a stable thermal environment for neonates. The device is classified as a Neonatal Incubator. It is used in general hospital settings.

The Infant Incubator is supplied with specifications that include a product code of FMZ and a regulation number of 880.5400. It has been authorized with an FDA 510K clearance. The device is intended for use in a general hospital setting, with a device class of 2. It is available with various features and models, including the TI-500 and C100-2, C200-1.

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