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Ventlab R500P21

by Ventlab Corp.

Ventlab R500P21 is a Class II device made by Ventlab Corp., cleared under FDA 510(k) K133540 on 28 Mar 2014 and listed in FDA GUDID since 18 Jul 2023 (UDI-DI 10889483227046), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K133540

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 Number10889483227046 UDI-DI Date18 Jul 2023ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK133540 Date28 Mar 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K133540 decided 28 Mar 2014 Active
  • FDA GUDID UDI-DI 10889483227046 listed 18 Jul 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K133540
  2. Listed FDA GUDID 10889483227046

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  • Withdrawn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 / Ref / Catalog
R500P21
Primary DI / UDI-DI
10889483227046
510(k) Number
FDA product code
CCK
GMDN term
Exhaled-gas oesophageal intubation detector
Device class
Class II
Regulation number
868.1400
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Exhaled-gas oesophageal intubation detector

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)