Skip to content

Innocor INN00400

by Innovision ApS

Innocor INN00400 is a Class II device made by Innovision ApS, cleared under FDA 510(k) K102047 on 1 Nov 2011 (3 earlier submissions) and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 05713867000056), 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

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05713867000056 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK102047 Date1 Nov 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K102047 decided 1 Nov 2011 Active· +3 more in the status table
  • FDA GUDID UDI-DI 05713867000056 listed 1 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2769-2016 FDA Class II initiated 13 May 2016

    The purpose of the recall is to replace data transmission cable (USB-cable) connecting the lnnocor device with an external computer. The replacement USB cable will provide galvanic isolation of the lnnocor from the external computer via opto-couplers, as opposed to the grounding protection currently in use. The replacement is intended to prevent risk of electric shock.

Timeline

6 dated events

  1. Cleared FDA 510(k) K051907
  2. Cleared FDA 510(k) K071911
  3. Cleared FDA 510(k) K083879
  4. Cleared FDA 510(k) K102047
  5. Recall initiated FDA recalls Z-2769-2016
  6. Listed FDA GUDID 05713867000056

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Innocor
Generic name
Pulmonary function analysis system, adult
Model / reference
INN00400
Primary DI / UDI-DI
05713867000056
510(k) Number
FDA product code
BZC, BZG, DQK
GMDN term
Pulmonary function analysis system, adult
Device class
Class II
Regulation number
868.1880, 868.1840, 870.1425
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulmonary function analysis system, adultCardiopulmonary stress exercise monitoring systemPulmonary function analysis system, paediatric

Cleared under the same submission (K051907)

and 8 more cleared under K051907

Cleared under the same submission (K071911)

and 8 more cleared under K071911

Similar devices

Other devices filed under FDA product code BZC (Calculator, Pulmonary Function Data).

Other devices from Innovision ApS

See all devices from Innovision ApS →

Properties

  • Serial number
Other properties (14, all answered No)