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Statsensor 1.0

by Nova Biomedical Corporation 5 variants

Statsensor 1.0 (52800) is a Class II device made by Nova Biomedical Corporation, cleared under FDA 510(k) K070068 on 7 May 2007 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 10385480528006), active as of 23 Oct 2026. 3 FDA recalls are 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

5 closed

Documents

510(k) K070068

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 Number10385480528006 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK070068 Date7 May 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K070068 decided 7 May 2007 Active
  • FDA GUDID UDI-DI 10385480528006 listed 20 Sep 2016 Listed

Recalls

5 recalls · FDA

    • Terminated Z-0650-2014 FDA Class II initiated 10 Oct 2013 on shared 510(k) K070068

    Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage

    • Terminated Z-1472-2008 FDA Unclassified (pre-2012) initiated 21 Feb 2008 on shared 510(k) K070068

    Lithium batteries may fail if the glucose or creatinine meters have been dropped.

  • 3 recalls, same reason

    • Terminated Z-0724-2008 FDA Unclassified (pre-2012) initiated 2 Nov 2007
    • Terminated Z-0726-2008 FDA Unclassified (pre-2012) initiated 2 Nov 2007
    • Terminated Z-0725-2008 FDA Unclassified (pre-2012) initiated 2 Nov 2007

    Incorrect Results - Creatinine results were lower than the laboratory reference method.

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

Timeline

7 dated events

  1. Cleared FDA 510(k) K070068
  2. Recall initiated FDA recalls Z-0724-2008
  3. Recall initiated FDA recalls Z-0726-2008
  4. Recall initiated FDA recalls Z-0725-2008
  5. Recall initiated FDA recalls Z-1472-2008
  6. Recall initiated FDA recalls Z-0650-2014
  7. Listed FDA GUDID 10385480528006

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Statsensor
Generic name
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Model / Ref / Catalog
1.0, 52800
Primary DI / UDI-DI
10385480528006
510(k) Number
FDA product code
CGL
GMDN term
Metabolic profile clinical chemistry analyser IVD, portable, semi-automated
Device class
Class II
Regulation number
862.1225
GUDID distribution status
In Commercial Distribution

Related devices

Category: Metabolic profile clinical chemistry analyser IVD, portable, semi-automated

Cleared under the same submission (K070068)

and 4 more cleared under K070068

Similar devices

Other devices filed under FDA product code CGL (ELECTRODE, ION BASED, ENZYMATIC, CREATININE).

Other devices from Nova Biomedical Corporation

See all devices from Nova Biomedical Corporation →

Properties

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