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Nonin 8004CB

by Nonin Medical, Inc.

Nonin 8004CB is a Class II device made by Nonin Medical, Inc., cleared under FDA 510(k) K132402 on 21 Feb 2014 (1 earlier submission) and listed in FDA GUDID since 24 Aug 2016 (UDI-DI 00849686074758), 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

2 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00849686074758 UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132402 Date21 Feb 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132402 decided 21 Feb 2014 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00849686074758 listed 24 Aug 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-0901-2015 FDA Class II initiated 25 Nov 2014 on shared 510(k) K132402

    Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or illness have been reported.

    • Terminated Z-0458-2010 FDA Unclassified (pre-2012) initiated 23 Oct 2009

    A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikely to occur, has the potential to cause a burn if the POD is in direct contact with the patient.

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

Timeline

5 dated events

  1. Cleared FDA 510(k) K090807
  2. Recall initiated FDA recalls Z-0458-2010
  3. Cleared FDA 510(k) K132402
  4. Recall initiated FDA recalls Z-0901-2015
  5. Listed FDA GUDID 00849686074758

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Nonin
Generic name
Cerebral oximeter sensor, single-use
Model / reference
8004CB
Primary DI / UDI-DI
00849686074758
510(k) Number
FDA product code
MUD
GMDN term
Cerebral oximeter sensor, single-use
Device class
Class II
Regulation number
870.2700
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Cerebral oximeter sensor, single-use

Cleared under the same submission (K090807)

and 6 more cleared under K090807

Cleared under the same submission (K132402)

and 2 more cleared under K132402

Similar devices in this category

Other devices filed under Cerebral oximeter sensor, single-use.

Other devices from Nonin Medical, Inc.

See all devices from Nonin Medical, Inc. →

Properties

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