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Vasocuff Cuff-200

by Newman Medical

Vasocuff Cuff-200 is a Class II device made by Newman Medical, cleared under FDA 510(k) K152468 on 29 Oct 2015 and listed in FDA GUDID since 6 Jul 2021 (UDI-DI 00852785008678), active as of 22 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 22 Oct 2026

Documents

510(k) K152468

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 Number00852785008678 UDI-DI Date6 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152468 Date29 Oct 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152468 decided 29 Oct 2015 Active
  • FDA GUDID UDI-DI 00852785008678 listed 6 Jul 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K152468
  2. Listed FDA GUDID 00852785008678

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vasocuff
Generic name
Blood pressure cuff, reusable
Model / Ref / Catalog
CUFF-200
Primary DI / UDI-DI
00852785008678
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
  • Serial number
Other properties (13, all answered No)