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Safety 1st IH509

by Dorel Juvenile Group, Inc. 3 variants

Safety 1st IH509 is a Class II device made by Dorel Juvenile Group, Inc., cleared under FDA 510(k) K101387 on 3 Aug 2010 and listed in FDA GUDID since 1 May 2021 (UDI-DI 10884392945319), 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) K101387

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 Number10884392945319 UDI-DI Date1 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK101387 Date3 Aug 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K101387 decided 3 Aug 2010 Active
  • FDA GUDID UDI-DI 10884392945319 listed 1 May 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K101387
  2. Listed FDA GUDID 10884392945319

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  • Withdrawn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
Infant care kit
Model / reference
IH509
Primary DI / UDI-DI
10884392945319
510(k) Number
FDA product code
FLL
GMDN term
Infant care kit
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: Infant care kit

Cleared under the same submission (K101387)

and 8 more cleared under K101387

Similar devices

Other devices filed under FDA product code FLL (Thermometer, Electronic, Clinical).

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)