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Regional Oximeter System, Model 7600

by Nonin Medical, Inc.

510(k) K090807

Regional Oximeter System, Model 7600 is a Class II device made by Nonin Medical, Inc., cleared under FDA 510(k) K090807 on 30 Jun 2009, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK090807 Date30 Jun 2009ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • 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.

Timeline

2 dated events

  1. Cleared FDA 510(k) K090807
  2. Recall initiated FDA recalls Z-0458-2010

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MUD
Device class
Class II
Regulation
21 CFR Part 870.2700
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K090807

11 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K090807
UDI-DISize and differences
Nonin 7600
Nonin Medical, Inc.
760000849686073775
Single use: no
On the market
Nonin 7600
Nonin Medical, Inc.
760000849686074123
Single use: no
On the market
Nonin 7600
Nonin Medical, Inc.
760000833166009743
Single use: no
On the market
Nonin 7600 TC-1
Nonin Medical, Inc.
7600 TC-100833166007619
Single use: no
On the market
Nonin 7600PA
Nonin Medical, Inc.
7600PA00833166003802
Single use: no
On the market
Nonin 8000CA
Nonin Medical, Inc.
8000CA00849686074147
Single use: yes
On the market
Nonin 8003CA
Nonin Medical, Inc.
8003CA00849686074765
Single use: yes
On the market
Nonin 8003CA
Nonin Medical, Inc.
8003CA00849686073195
Single use: yes
On the market
Nonin 8004CA
Nonin Medical, Inc.
8004CA00849686074772
Single use: yes
On the market
Nonin 8004CB
Nonin Medical, Inc.
8004CB00849686074758
Single use: yes
On the market
Nonin 8004CB-NA
Nonin Medical, Inc.
8004CB-NA00849686073362
Single use: yes
On the market

Similar devices

Other devices filed under FDA product code MUD (Oximeter, Tissue Saturation).

Other devices from Nonin Medical, Inc.

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