Statcorp Medical

by Statcorp Medical 231 variants

Statcorp Medical 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 24 Oct 2016 (UDI-DI 50841522111493), active as of 1 Jun 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 1 Jun 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 1 Jun 2026.

Regulatory status

as of registry sync 1 Jun 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number50841522111493 UDI-DI	Date24 Oct 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK940214	Date22 Feb 1994Decided	StatusActive

Official records

AccessGUDID record UDI-DI 50841522111493
FDA 510(k) database 510(k) number K940214

Across registries

2 registries list this device

FDA 510(k) K940214 decided 22 Feb 1994 Active
FDA GUDID UDI-DI 50841522111493 listed 24 Oct 2016 Listed

Timeline

2 dated events

22 Feb 1994 Cleared FDA 510(k) K940214
24 Oct 2016 Listed FDA GUDID 50841522111493

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Blood pressure cuff, single-use
Model / Ref / Catalog: STATCORP

Primary DI / UDI-DI: 50841522111493
510(k) Number: K940214
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

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Properties

Single use
Lot / batch number

Other properties (13, all answered No)