Skip to content

Drive MQ0385

by Drive Devilbiss Healthcare

Drive MQ0385 is a Class II device made by Drive Devilbiss Healthcare, cleared under FDA 510(k) K091272 on 10 Nov 2009 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00822383538396), 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 Number00822383538396 UDI-DI Date16 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 00822383538396 listed 16 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 00822383538396
  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  • Withdrawn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
Drive
Generic name
Infant oral pacifier
Model / reference
MQ0385
Primary DI / UDI-DI
00822383538396
510(k) Number
FDA product code
CAF
GMDN term
Infant oral pacifier
Device class
Class II
Regulation number
868.5630
GUDID distribution status
In Commercial Distribution

Related devices

Category: Infant oral pacifier

Cleared under the same submission (K091272)

and 8 more cleared under K091272

Similar devices

Also classified as Infant oral pacifier.

Similar devices

Other devices filed under FDA product code CAF (NEBULIZER (DIRECT PATIENT INTERFACE)).

Other devices from Drive Devilbiss Healthcare

See all devices from Drive Devilbiss Healthcare →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)