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SourceMark M0645C

by Sourcemark, LLC. 2 variants

SourceMark M0645C is a Class II device made by Sourcemark, LLC., cleared under FDA 510(k) K042683 on 18 Feb 2005 and listed in FDA GUDID since 27 Sep 2019 (UDI-DI 00897392001704), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00897392001704 UDI-DI Date27 Sep 2019ListedStatusListed 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 00897392001704 listed 27 Sep 2019 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 00897392001704
  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  • Withdrawn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
SourceMark
Generic name
Basic endotracheal tube, single-use
Model / reference
M0645C
Primary DI / UDI-DI
00897392001704
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

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 Sourcemark, LLC.

See all devices from Sourcemark, LLC. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)