Skip to content

SoftCheck BP Cuffs

by Statcorp Medical 183 variants

SoftCheck BP Cuffs (DT3544) is a Class II device made by Statcorp Medical, cleared under FDA 510(k) K940214 on 22 Feb 1994 and listed in FDA GUDID since 19 Oct 2016 (UDI-DI 10841522106552), 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) K940214

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 Number10841522106552 UDI-DI Date19 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK940214 Date22 Feb 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K940214 decided 22 Feb 1994 Active
  • FDA GUDID UDI-DI 10841522106552 listed 19 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K940214
  2. Listed FDA GUDID 10841522106552

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Softcheck
Generic name
Blood pressure cuff, single-use
Model / Ref / Catalog
SoftCheck BP Cuffs, DT3544
Primary DI / UDI-DI
10841522106552
510(k) Number
FDA product code
DXQ
GMDN term
Blood pressure cuff, single-use
Device class
Class II
Regulation number
870.1120
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood pressure cuff, single-use

Cleared under the same submission (K940214)

and 8 more cleared under K940214

Similar devices

Other devices filed under FDA product code DXQ (blood pressure cuff).

Other devices from Statcorp Medical

See all devices from Statcorp Medical →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)