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O3 4616

by Masimo Corporation

O3 4616 is a Class II device made by Masimo Corporation, cleared under FDA 510(k) K201432 on 29 Aug 2020 and listed in FDA GUDID since 8 Oct 2021 (UDI-DI 00843997014557), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K201432

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00843997014557 UDI-DI Date8 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201432 Date29 Aug 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201432 decided 29 Aug 2020 Active
  • FDA GUDID UDI-DI 00843997014557 listed 8 Oct 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201432
  2. Listed FDA GUDID 00843997014557

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
O3
Generic name
Cerebral oximeter
Model / reference
4616
Primary DI / UDI-DI
00843997014557
FDA product code
MUD
GMDN term
Cerebral oximeter
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cerebral oximeter

Cleared under the same submission (K201432)

Similar devices

Also classified as Cerebral oximeter.

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)