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Strive® Peak Flow Meter, cs/10

by Monaghan Medical Corp.

Strive® Peak Flow Meter, cs/10 is a Class II device made by Monaghan Medical Corp., cleared under FDA 510(k) K123945 on 17 Apr 2013 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00604351966109), active as of 23 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 23 Oct 2026

Documents

510(k) K123945

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00604351966109 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123945 Date17 Apr 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123945 decided 17 Apr 2013 Active
  • FDA GUDID UDI-DI 00604351966109 listed 20 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123945
  2. Listed FDA GUDID 00604351966109

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Strive®
Generic name
Peak flow meter, manual
Model / reference
Peak Flow Meter, cs/10
Primary DI / UDI-DI
00604351966109
510(k) Number
FDA product code
BZH
GMDN term
Peak flow meter, manual
Device class
Class II
Regulation number
868.1860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Peak flow meter, manual

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Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)