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Tech-Med 2050

by Dukal LLC

Tech-Med 2050 is a Class II device made by Dukal LLC, cleared under FDA 510(k) K780715 on 17 Jul 1978 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00665973016962), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K780715

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00665973016962 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK780715 Date17 Jul 1978DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K780715 decided 17 Jul 1978 Active
  • FDA GUDID UDI-DI 00665973016962 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K780715
  2. Listed FDA GUDID 00665973016962

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Tech-Med
Generic name
Blood pressure cuff, reusable
Model / Ref / Catalog
2050
Primary DI / UDI-DI
00665973016962
510(k) Number
FDA product code
DXQ
GMDN term
Blood pressure cuff, reusable
Device class
Class II
Regulation number
870.1120
GUDID distribution status
Not in Commercial Distribution
Size
Weight — 0.88 Kilogram

Related devices

Cleared under the same submission (K780715)

Similar devices

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

Other devices from Dukal LLC

See all devices from Dukal LLC →

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)