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Ventlab SC300

by Ventlab Corp.

Ventlab SC300 is a Class II device made by Ventlab Corp., cleared under FDA 510(k) K093525 on 10 Dec 2009 and listed in FDA GUDID since 26 Sep 2016 (UDI-DI 10889483109243), 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) K093525

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 Number10889483109243 UDI-DI Date26 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK093525 Date10 Dec 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K093525 decided 10 Dec 2009 Active
  • FDA GUDID UDI-DI 10889483109243 listed 26 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1880-2016 FDA Class II initiated 15 Mar 2016

    Stat-check CO2 indicators are non-functional. The indicator is yellow when not in use and should be purple when not in use. The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly. The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.

Timeline

3 dated events

  1. Cleared FDA 510(k) K093525
  2. Recall initiated FDA recalls Z-1880-2016
  3. Listed FDA GUDID 10889483109243

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ventlab
Generic name
Exhaled-gas oesophageal intubation detector
Model / reference
SC300
Primary DI / UDI-DI
10889483109243
FDA product code
CCK
GMDN term
Exhaled-gas oesophageal intubation detector
Device class
Class II
Regulation number
868.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Exhaled-gas oesophageal intubation detector

Cleared under the same submission (K093525)

Similar devices

Other devices filed under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase).

Other devices from Ventlab Corp.

See all devices from Ventlab Corp. →

Properties

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