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4509

by GaleMed Corporation

4509 (Disposable Connecting Tube) is a Class II device made by GaleMed Corporation, cleared under FDA 510(k) K022124 on 3 Apr 2003 and listed in FDA GUDID since 15 Oct 2015 (UDI-DI 24710810084601), active as of 12 Nov 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 12 Nov 2026

Documents

510(k) K022124

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number24710810084601 UDI-DI Date15 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK022124 Date3 Apr 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K022124 decided 3 Apr 2003 Active
  • FDA GUDID UDI-DI 24710810084601 listed 15 Oct 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K022124
  2. Listed FDA GUDID 24710810084601

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Peak flow meter, manual
Model / Ref / Catalog
4509, Disposable Connecting Tube
Primary DI / UDI-DI
24710810084601
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

Cleared under the same submission (K022124)

Other devices from GaleMed Corporation

See all devices from GaleMed Corporation →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)