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Stat Profile Phox Basic

by Nova Biomedical Corporation 3 variants

Stat Profile Phox Basic (35349) is a Class II device made by Nova Biomedical Corporation, cleared under FDA 510(k) K141907 on 29 May 2015 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00385480353496), active as of 23 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

510(k) K141907

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 Number00385480353496 UDI-DI Date20 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 00385480353496 listed 20 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2732-2017 FDA Class II initiated 19 Jun 2017

    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.

Timeline

3 dated events

  1. Cleared FDA 510(k) K141907
  2. Listed FDA GUDID 00385480353496
  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  • Withdrawn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

Trade name
Stat Profile
Generic name
Co-oximetry analyser IVD, point-of-care
Model / Ref / Catalog
PHOX BASIC, 35349
Primary DI / UDI-DI
00385480353496
510(k) Number
FDA product code
JPK, CHL, JIX
GMDN term
Co-oximetry analyser IVD, point-of-care
Device class
Class II
Regulation number
864.8625, 862.1120, 862.1150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Co-oximetry analyser IVD, point-of-care

Cleared under the same submission (K141907)

and 8 more cleared under K141907

Similar devices

Other devices filed under FDA product code JPK (MIXTURE, HEMATOLOGY QUALITY CONTROL).

Other devices from Nova Biomedical Corporation

See all devices from Nova Biomedical Corporation →

Properties

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