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UltraCheck BP Cuffs

by Statcorp Medical 169 variants

UltraCheck BP Cuffs (US1826MHP) is a Class II device made by Statcorp Medical, cleared under FDA 510(k) K954282 on 6 Feb 1996 and listed in FDA GUDID since 5 Oct 2016 (UDI-DI 10841522110467), 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) K954282

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 Number10841522110467 UDI-DI Date5 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK954282 Date6 Feb 1996DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K954282 decided 6 Feb 1996 Active
  • FDA GUDID UDI-DI 10841522110467 listed 5 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K954282
  2. Listed FDA GUDID 10841522110467

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ultracheck
Generic name
Blood pressure cuff, reusable
Model / Ref / Catalog
UltraCheck BP Cuffs, US1826MHP
Primary DI / UDI-DI
10841522110467
510(k) Number
FDA product code
DXQ
GMDN term
Blood pressure cuff, reusable
Device class
Class II
Regulation number
870.1120
GUDID distribution status
In Commercial Distribution

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Properties

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