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Infant Flow System

by Sensor Medics Corp. 2 variants

510(k) K974303

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 NumberK974303 Date30 Jan 1998ClearedStatusActive

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  • Withdrawn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
BZD
Device Class
Class II
Regulation
21 CFR Part 868.5905
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Flow System is a ventilator, non-continuous (respirator) designed to deliver continuous positive airway pressure (CPAP) to newborns and infants. It provides respiratory support to stabilize breathing and assist in managing respiratory distress, including conditions such as respiratory distress syndrome (RDS).

This system comprises a Driver unit and nasal continuous positive airway pressure (NCPAP) prongs, intended for use in hospital settings by clinicians. It is supplied as a reusable device and is classified under FDA regulation number 868.5905 with a 510(k) clearance (K974303). The device is intended for single-patient use per session and requires proper storage and handling as specified in its instructions.

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