Skip to content

In-Check 3109831

by Clement Clarke International Limited

In-Check 3109831 is a Class II device made by Clement Clarke International Limited, cleared under FDA 510(k) K980960 on 10 Jun 1998 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI 05023323000804), 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) K980960

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 Number05023323000804 UDI-DI Date7 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK980960 Date10 Jun 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K980960 decided 10 Jun 1998 Active
  • FDA GUDID UDI-DI 05023323000804 listed 7 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K980960
  2. Listed FDA GUDID 05023323000804

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
In-Check
Generic name
Incentive spirometer
Model / Ref / Catalog
3109831
Primary DI / UDI-DI
05023323000804
510(k) Number
FDA product code
BZH
GMDN term
Incentive spirometer
Device class
Class II
Regulation number
868.1860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Incentive spirometer

Cleared under the same submission (K980960)

and 3 more cleared under K980960

Similar devices

Other devices filed under FDA product code BZH (Meter, Peak Flow, Spirometry).

Other devices from Clement Clarke International Limited

See all devices from Clement Clarke International Limited →

Properties

  • Lot / batch number
  • Manufacturing date
Other properties (13, all answered No)