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Nova

by Nova Biomedical Corporation 8 variants

Nova (14071) is a Class I device made by Nova Biomedical Corporation, cleared under FDA 510(k) K141907 on 29 May 2015 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 00385480140713), active as of 8 Jun 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

1 closed

Documents

510(k) K141907

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Jun 2026.

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00385480140713 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK141907 Date29 May 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K141907 decided 29 May 2015 Active
  • FDA GUDID UDI-DI 00385480140713 listed 16 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2732-2017 FDA Class II initiated 19 Jun 2017 on shared 510(k) K141907

    Software- scheduled A-QC analysis could initiate prior to a patient result being released by the operator and result in the pending patient result being overwritten with the A-QC test results.

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K141907
  2. Listed FDA GUDID 00385480140713
  3. Recall initiated FDA recalls Z-2732-2017

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Model / Ref / Catalog
A, 14071
Primary DI / UDI-DI
00385480140713
510(k) Number
FDA product code
JJY
GMDN term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Cleared under the same submission (K141907)

and 8 more cleared under K141907

Similar devices in this category

Other devices filed under Multiple blood gas/haemoximetry/electrolyte analyte IVD, control.

Other devices from Nova Biomedical Corporation

See all devices from Nova Biomedical Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)