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Safety 1st TH114

by Dorel Juvenile Group, Inc.

Safety 1st TH114 is a Class II device made by Dorel Juvenile Group, Inc., cleared under FDA 510(k) K203731 on 26 Sep 2021 and listed in FDA GUDID since 28 May 2026 (UDI-DI 00884392020613), active as of 23 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 23 Oct 2026

Documents

510(k) K203731

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884392020613 UDI-DI Date28 May 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK203731 Date26 Sep 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203731 decided 26 Sep 2021 Active
  • FDA GUDID UDI-DI 00884392020613 listed 28 May 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203731
  2. Listed FDA GUDID 00884392020613

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Safety 1st
Generic name
Intermittent electronic patient thermometer
Model / reference
TH114
Primary DI / UDI-DI
00884392020613
510(k) Number
FDA product code
FLL
GMDN term
Intermittent electronic patient thermometer
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K203731)

Similar devices

Other devices filed under FDA product code FLL (Continuous Measurement Thermometer).

Other devices from Dorel Juvenile Group, Inc.

See all devices from Dorel Juvenile Group, Inc. →

Properties

  • Lot / batch number
Other properties (14, all answered No)