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Med-Tech Resource CP6331

by Med-Tech Resource, LLC

Med-Tech Resource CP6331 is a Class II device made by Med-Tech Resource, LLC, cleared under FDA 510(k) K210288 on 26 Aug 2021 and listed in FDA GUDID since 2 Jun 2025 (UDI-DI 00850075255030), 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) K210288

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 Number00850075255030 UDI-DI Date2 Jun 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210288 Date26 Aug 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210288 decided 26 Aug 2021 Active
  • FDA GUDID UDI-DI 00850075255030 listed 2 Jun 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K210288
  2. Listed FDA GUDID 00850075255030

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Med-Tech Resource
Generic name
Pulmonary resuscitator, manual, reusable
Model / reference
CP6331
Primary DI / UDI-DI
00850075255030
510(k) Number
FDA product code
BTM
GMDN term
Pulmonary resuscitator, manual, reusable
Device class
Class II
Regulation number
868.5915
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulmonary resuscitator, manual, reusable

Cleared under the same submission (K210288)

and 8 more cleared under K210288

Similar devices

Other devices filed under FDA product code BTM (Ventilator, Emergency, Manual (Resuscitator)).

Other devices from Med-Tech Resource, LLC

See all devices from Med-Tech Resource, LLC →

Properties

  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (12, all answered No)