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Main Module, Digital FlushMount 27192-FRU

by Accutron

Main Module, Digital FlushMount 27192-FRU is a Class II device made by Accutron, cleared under FDA 510(k) K052335 on 23 Nov 2005 and listed in FDA GUDID since 31 Aug 2018 (UDI-DI 00813830027730), active as of 22 Oct 2026. 4 FDA recalls are 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

4 closed

Documents

510(k) K052335

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 Number00813830027730 UDI-DI Date31 Aug 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK052335 Date23 Nov 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052335 decided 23 Nov 2005 Active
  • FDA GUDID UDI-DI 00813830027730 listed 31 Aug 2018 Listed

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0017-2013 FDA Class I initiated 29 Apr 2012
    • Terminated Z-0018-2013 FDA Class I initiated 29 Apr 2012
    • Terminated Z-0020-2013 FDA Class I initiated 29 Apr 2012
    • Terminated Z-0019-2013 FDA Class I initiated 29 Apr 2012

    Accutron is recalling the Flowmeter (Analgesia Gas Machine) because when it flows Nitrous Gas without Oxygen gas being turned on, it functions in an incorrect manner.

Timeline

6 dated events

  1. Cleared FDA 510(k) K052335
  2. Recall initiated FDA recalls Z-0017-2013
  3. Recall initiated FDA recalls Z-0018-2013
  4. Recall initiated FDA recalls Z-0020-2013
  5. Recall initiated FDA recalls Z-0019-2013
  6. Listed FDA GUDID 00813830027730

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Main Module, Digital FlushMount
Generic name
Oxygen/air/nitrous oxide breathing gas mixer
Model / Ref / Catalog
27192-FRU
Primary DI / UDI-DI
00813830027730
510(k) Number
FDA product code
BSZ
GMDN term
Oxygen/air/nitrous oxide breathing gas mixer
Device class
Class II
Regulation number
868.5160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Oxygen/air/nitrous oxide breathing gas mixer

Cleared under the same submission (K052335)

and 8 more cleared under K052335

Similar devices

Other devices filed under FDA product code BSZ (Gas-Machine, Anesthesia).

Other devices from Accutron

See all devices from Accutron →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)