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Topcare 87-930-004

by Topco Associates, LLC

Topcare 87-930-004 is a Class II device made by Topco Associates, LLC, cleared under FDA 510(k) K041516 on 8 Sep 2004 and listed in FDA GUDID since 13 Sep 2016 (UDI-DI 00036800396937), active as of 23 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K041516

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 Number00036800396937 UDI-DI Date13 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK041516 Date8 Sep 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K041516 decided 8 Sep 2004 Active
  • FDA GUDID UDI-DI 00036800396937 listed 13 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0506-2012 FDA Unclassified (pre-2012) initiated 23 Nov 2011

    The thermometers have been reported to have inaccurate readings

Timeline

3 dated events

  1. Cleared FDA 510(k) K041516
  2. Recall initiated FDA recalls Z-0506-2012
  3. Listed FDA GUDID 00036800396937

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Topcare
Generic name
Continuous electronic patient thermometer, battery-powered
Model / Ref / Catalog
87-930-004
Primary DI / UDI-DI
00036800396937
510(k) Number
FDA product code
FLL
GMDN term
Continuous electronic patient thermometer, battery-powered
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: Continuous electronic patient thermometer, battery-powered

Cleared under the same submission (K041516)

and 8 more cleared under K041516

Similar devices

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

Other devices from Topco Associates, LLC

See all devices from Topco Associates, LLC →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)