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Ampmed AMPCA2W

by Amplim, LLC

Ampmed AMPCA2W is a Class II device made by Amplim, LLC, cleared under FDA 510(k) K191251 on 15 Oct 2019 and listed in FDA GUDID since 21 May 2021 (UDI-DI 00810477023668), 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) K191251

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 Number00810477023668 UDI-DI Date21 May 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK191251 Date15 Oct 2019IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191251 decided 15 Oct 2019 Active
  • FDA GUDID UDI-DI 00810477023668 listed 21 May 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K191251
  2. Listed FDA GUDID 00810477023668

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ampmed
Generic name
Infrared patient thermometer, skin
Model / reference
AMPCA2W
Primary DI / UDI-DI
00810477023668
510(k) Number
FDA product code
FLL
GMDN term
Infrared patient thermometer, skin
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: Infrared patient thermometer, skin

Cleared under the same submission (K191251)

and 7 more cleared under K191251

Similar devices

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

Other devices from Amplim, LLC

See all devices from Amplim, LLC →

Properties

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