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ViSi Disposable Adult Cuff, Medium+ (Qty 20)

by Sotera Wireless

ViSi Disposable Adult Cuff, Medium+ (Qty 20) (94-10191) is a Class II device made by Sotera Wireless, cleared under FDA 510(k) K152341 on 14 Dec 2015 and listed in FDA GUDID since 24 Jun 2020 (UDI-DI 00850733007247), 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) K152341

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 Number00850733007247 UDI-DI Date24 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK152341 Date14 Dec 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K152341 decided 14 Dec 2015 Active
  • FDA GUDID UDI-DI 00850733007247 listed 24 Jun 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K152341
  2. Listed FDA GUDID 00850733007247

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ViSi
Generic name
Blood pressure cuff, single-use
Model / Ref / Catalog
Disposable Adult Cuff, Medium+ (Qty 20), 94-10191
Primary DI / UDI-DI
00850733007247
510(k) Number
FDA product code
DXN
GMDN term
Blood pressure cuff, single-use
Device class
Class II
Regulation number
870.1130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood pressure cuff, single-use

Cleared under the same submission (K152341)

and 8 more cleared under K152341

Similar devices

Other devices filed under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive).

Other devices from Sotera Wireless

See all devices from Sotera Wireless →

Properties

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