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Customed 712057143009

by Customed, Inc.

Customed 712057143009 (9003009) is a Class II device made by Customed, Inc., cleared under FDA 510(k) K042683 on 18 Feb 2005 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI M20890030090), 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

1 ongoing

This device is named in the recall

Documents

510(k) K042683

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 NumberM20890030090 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK042683 Date18 Feb 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K042683 decided 18 Feb 2005 Active
  • FDA GUDID UDI-DI M20890030090 listed 23 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-3172-2026 FDA Class II initiated 31 Jul 2026

    The 6Fr suction catheter could not pass through the samples smoothly.

Timeline

3 dated events

  1. Cleared FDA 510(k) K042683
  2. Listed FDA GUDID M20890030090
  3. Recall initiated FDA recalls Z-3172-2026

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  • Withdrawn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
Basic endotracheal tube, single-use
Model / Ref / Catalog
712057143009, 9003009
Primary DI / UDI-DI
M20890030090
510(k) Number
FDA product code
BTR
GMDN term
Basic endotracheal tube, single-use
Device class
Class II
Regulation number
868.5730
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 6.0 Millimeter

Related devices

Category: Basic endotracheal tube, single-use

Cleared under the same submission (K042683)

and 8 more cleared under K042683

Similar devices in this category

Other devices filed under Basic endotracheal tube, single-use.

Other devices from Customed, Inc.

See all devices from Customed, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)