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ActiFog™ 6505

by Medical Action Industries Inc.

ActiFog™ 6505 is a Class II device made by Medical Action Industries Inc., cleared under FDA 510(k) K932449 on 11 Aug 1993 and listed in FDA GUDID since 20 Aug 2016 (UDI-DI 10809160022757), active as of 23 Oct 2026.

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

2 closed

Documents

510(k) K932449

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 Number10809160022757 UDI-DI Date20 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK932449 Date11 Aug 1993DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K932449 decided 11 Aug 1993 Active
  • FDA GUDID UDI-DI 10809160022757 listed 20 Aug 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0897-05 FDA Unclassified (pre-2012) initiated 15 May 2005 on shared 510(k) K932449

    An improper expiration date was placed on the individual packages, although the dispenser box and carton contained the correct expiration date.

    • Terminated Z-0828-03 FDA Unclassified (pre-2012) initiated 30 Apr 2003 on shared 510(k) K932449

    Sterility compromised - incomplete sterile package seal.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K932449
  2. Recall initiated FDA recalls Z-0828-03
  3. Recall initiated FDA recalls Z-0897-05
  4. Listed FDA GUDID 10809160022757

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ActiFog™
Generic name
Endoscope cleaning kit
Model / reference
6505
Primary DI / UDI-DI
10809160022757
510(k) Number
FDA product code
OCT
GMDN term
Endoscope cleaning kit
Device class
Class II
Regulation number
876.1500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Endoscope cleaning kit

Cleared under the same submission (K932449)

and 8 more cleared under K932449

Other devices from Medical Action Industries Inc.

See all devices from Medical Action Industries Inc. →

Properties

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