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Blood Pressure Kit Sphygmomanometer with Stethoscope 7100

by Dynarex Corp.

Blood Pressure Kit Sphygmomanometer with Stethoscope 7100 is a Class II device made by Dynarex Corp., cleared under FDA 510(k) K092245 on 28 Oct 2009 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00616784710020), 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) K092245

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 Number00616784710020 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK092245 Date28 Oct 2009IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K092245 decided 28 Oct 2009 Active
  • FDA GUDID UDI-DI 00616784710020 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K092245
  2. Listed FDA GUDID 00616784710020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Blood Pressure Kit Sphygmomanometer with Stethoscope
Generic name
Aneroid manual sphygmomanometer
Model / reference
7100
Primary DI / UDI-DI
00616784710020
FDA product code
DXQ, LDE
GMDN term
Aneroid manual sphygmomanometer
Device class
Class II
Regulation number
870.1120, 870.1875
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code DXQ (Blood Pressure Cuff).

Other devices from Dynarex Corp.

See all devices from Dynarex Corp. →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)