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Omni Infant Phototherapy Unit

by Rocky Mountain Medical Corp.

510(k) K834430

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK834430 Date30 Apr 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
LBI
Device Class
Class II
Regulation
21 CFR Part 880.5700
Advisory Committee
General Hospital
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 Omni Infant Phototherapy Unit is a neonatal phototherapy device designed to treat hyperbilirubinemia (jaundice) in newborns. It emits specific wavelengths of light to reduce elevated serum bilirubin levels, typically used in neonatal intensive care units or general hospital settings. The device may include patient supports and associated components to facilitate therapy.

This device is supplied as a reusable medical instrument and is classified under FDA Product Code LBI as a Class II device under 21 CFR. It was granted FDA 510(k) clearance (K834430) in 1984 for substantial equivalence to a predicate device. The unit is intended for use in hospital environments and adheres to regulatory standards outlined in 21 CFR 880.5700.

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