Ampmed AMP1910

by Amplim, LLC 2 variants

Ampmed AMP1910 is a Class II device made by Amplim, LLC, cleared under FDA 510(k) K160019 on 22 Apr 2016 and listed in FDA GUDID since 21 May 2019 (UDI-DI 00810477022319), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00810477022319 UDI-DI	Date21 May 2019Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK160019	Date22 Apr 2016Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00810477022319
FDA 510(k) database 510(k) number K160019

Across registries

2 registries list this device

FDA 510(k) K160019 decided 22 Apr 2016 Active
FDA GUDID UDI-DI 00810477022319 listed 21 May 2019 Listed

Timeline

2 dated events

22 Apr 2016 Cleared FDA 510(k) K160019
21 May 2019 Listed FDA GUDID 00810477022319

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Ampmed
Generic name: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Model / reference: AMP1910

Primary DI / UDI-DI: 00810477022319
510(k) Number: K160019
FDA product code: DXN
GMDN term: Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Device class: Class II
Regulation number: 870.1130
GUDID distribution status: In Commercial Distribution

Similar devices in this category

Other devices filed under Automatic-inflation electronic sphygmomanometer, portable, arm/wrist.

Other devices from Amplim, LLC

See all devices from Amplim, LLC →

Properties

Lot / batch number
Serial number
Manufacturing date

Other properties (12, all answered No)