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Radius PPG 4778

by Masimo Corporation

Radius PPG 4778 is a Class II device made by Masimo Corporation, cleared under FDA 510(k) K203215 on 11 Jun 2021 and listed in FDA GUDID since 8 Oct 2021 (UDI-DI 00843997016155), 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) K203215

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 Number00843997016155 UDI-DI Date8 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK203215 Date11 Jun 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203215 decided 11 Jun 2021 Active
  • FDA GUDID UDI-DI 00843997016155 listed 8 Oct 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203215
  2. Listed FDA GUDID 00843997016155

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Radius PPG
Generic name
Wireless patient thermometer, single-use
Model / reference
4778
Primary DI / UDI-DI
00843997016155
510(k) Number
FDA product code
FLL
GMDN term
Wireless patient thermometer, single-use
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wireless patient thermometer, single-use

Cleared under the same submission (K203215)

Other devices from Masimo Corporation

See all devices from Masimo Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)