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Customed 712057143106

by Customed, Inc.

Customed 712057143106 (9003106) is a Class II device made by Customed, Inc., cleared under FDA 510(k) K091272 on 10 Nov 2009 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI M20890031060), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K091272

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 NumberM20890031060 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK091272 Date10 Nov 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091272 decided 10 Nov 2009 Active
  • FDA GUDID UDI-DI M20890031060 listed 23 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1058-2019 FDA Class II initiated 29 Aug 2018

    The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off.

Timeline

3 dated events

  1. Cleared FDA 510(k) K091272
  2. Listed FDA GUDID M20890031060
  3. Recall initiated FDA recalls Z-1058-2019

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Customed
Generic name
Nebulizing system delivery set, single-use
Model / Ref / Catalog
712057143106, 9003106
Primary DI / UDI-DI
M20890031060
510(k) Number
FDA product code
CAF
GMDN term
Nebulizing system delivery set, single-use
Device class
Class II
Regulation number
868.5630
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 6 Milliliter

Related devices

Category: Nebulizing system delivery set, single-use

Cleared under the same submission (K091272)

and 8 more cleared under K091272

Similar devices

Other devices filed under FDA product code CAF (Nebulizer (Direct Patient Interface)).

Other devices from Customed, Inc.

See all devices from Customed, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)