Skip to content

MLCi2™ 1525724

by Elekta Inc.

MLCi2 1525724 is a nitrous oxide/oxygen refillable cylinder (FDA Class II; FDA product code IYE, Accelerator, linear, medical) made by Elekta Inc., cleared under FDA 510(k) K082122 on 29 Aug 2008 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 05060191071024), 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

None ongoing

1 closed

Documents

510(k) K082122

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 Number05060191071024 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK082122 Date29 Aug 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082122 decided 29 Aug 2008 Active
  • FDA GUDID UDI-DI 05060191071024 listed 24 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1651-2012 FDA Not yet classified initiated 19 Apr 2012

    The Y2 diaphragm block was found loose.

Timeline

3 dated events

  1. Cleared FDA 510(k) K082122
  2. Recall initiated FDA recalls Z-1651-2012
  3. Listed FDA GUDID 05060191071024

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MLCi2™
Generic name
Nitrous oxide/oxygen refillable cylinder
Model / reference
1525724
Primary DI / UDI-DI
05060191071024
510(k) Number
FDA product code
IYE
GMDN term
Nitrous oxide/oxygen refillable cylinder
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Nitrous oxide/oxygen refillable cylinder

Similar devices

Other devices filed under FDA product code IYE (Accelerator, linear, medical).

Other devices from Elekta Inc.

  • XVI 1526927

    Class II

  • Elekta Unity 1536549

    Class II

  • 1525333

    Class II

  • 1525332

    Class II

See all devices from Elekta Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)