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Coda® CAFK-901

by LifeGlobal Group, LLC

Coda® CAFK-901 is a Class II device made by LifeGlobal Group, LLC, cleared under FDA 510(k) K001486 on 15 Sep 2000 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00815965021355), active as of 22 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 found

in data synced 22 Oct 2026

Documents

510(k) K001486

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 Number00815965021355 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK001486 Date15 Sep 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K001486 decided 15 Sep 2000 Active
  • FDA GUDID UDI-DI 00815965021355 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K001486
  2. Listed FDA GUDID 00815965021355

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Coda®
Generic name
Non-respiratory device ambient air filter
Model / Ref / Catalog
CAFK-901
Primary DI / UDI-DI
00815965021355
510(k) Number
FDA product code
MQG
GMDN term
Non-respiratory device ambient air filter
Device class
Class II
Regulation number
884.6120
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code MQG (ACCESSORY, ASSISTED REPRODUCTION).

Other devices from LifeGlobal Group, LLC

See all devices from LifeGlobal Group, LLC →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)