510(k) Report

510(k) · Cleared

Recalled · 2009

Regional Oximeter System, Model 7600

K090807510(k) TraditionalCleared Jun 30, 200997-day reviewClass II21 CFR 870.2700Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nonin Medical, Inc. · MUD Oximeter, Tissue Saturation

Cleared on Jun 30, 2009 as substantially equivalent to K001842 (Somanetics Corp., 2000) after a 97-day review. Its family tree reaches back 1 generation to 2000. 54 later devices descend from it. It has been recalled once.

Decided
Jun 30, 2009
Review
97 days
Class
Class II
Product code
MUD
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K001842 (2000). 54 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2019: 4 descendants cleared2015: 2 descendants cleared2014: 2 descendants cleared2013: 1 descendant cleared2012: 1 descendant cleared2016: 2 descendants cleared2020: 3 descendants cleared2022: 6 descendants cleared2018: 1 descendant cleared2021: 7 descendants cleared2017: 1 descendant cleared2024: 6 descendants cleared2023: 8 descendants cleared2025: 6 descendants cleared2026: 3 descendants clearedK001842 · Adult/Pediatric Cerebral Oximeter, Model Invos 5100 · Somanetics Corp. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 6 descendants3 generations forward: 4 descendants4 generations forward: 7 descendants5 generations forward: 6 descendants6 generations forward: 11 descendants7 generations forward: 13 descendants8 generations forward: 6 descendants K001842 · Adult/Pediatric Cerebral Oximeter, Model Invos 5100 · Somanetics Corp. · 20000+5
  1. Root · 1 generation backK001842 Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp. · 2000
  2. This deviceK090807 Regional Oximeter System, Model 7600Nonin Medical, Inc. · 2009
  3. Descendant · cites it directly · 53 of its ownK102715 Regional OximeterNonin Medical, Inc. · 2010
  4. Descendant · 2 generations on · 44 of its ownK133879 Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2014
  5. Descendant · 2 generations on · 42 of its ownK113215 Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc. · 2012
  6. Descendant · 3 generations on · 37 of its ownK143675 FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2015 · Recalled
  7. Descendant · 4 generations on · 34 of its ownK190205 HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019

Showing 5 of 54 descendants. See all descendants

Descendants cleared per year

2010: 12012: 12013: 12014: 22015: 22016: 22017: 12018: 12019: 42020: 32021: 72022: 62023: 82024: 62025: 62026: 3
2010high 8 (2023) · low 0 (2011)2026

Most influential descendants

Showing 5 of 54 · See all
  • K102715Regional OximeterNonin Medical, Inc. · 2010 · cites it directly53descendants
  • K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2014 · 2 generations on44descendants
  • K113215Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc. · 2012 · 2 generations on42descendants
  • K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc. · 2015 · 3 generations on37descendants
  • K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC · 2019 · 4 generations on34descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K001842Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp.2000—
0 (this device)K090807Regional Oximeter System, Model 7600Nonin Medical, Inc.2009—
+1K102715Regional OximeterNonin Medical, Inc.2010—
+2K133879Fore-Sight Elite Absolute Tissue OximeterCas Medical Systems, Inc.2014—
+2K113215Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc.2012—
+3K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc.20151
+4K190205HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry ModuleEdwards Lifesciences, LLC2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201310
201420
201520
201620
201710
201810
201940
202030
202170
202260
202380
202460
202560
202630
FIG. 1 — Lineage of K090807, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MUD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MUD device

  1. #1 K223651 Cerebral Adaptive Index (CAI) Algorithmscore 19.8 · 29 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K001842Adult/Pediatric Cerebral Oximeter, Model Invos 5100
Summary page 1
…o the INVOSI Model 5100 Cerebral Oximeter manufactured by Somnanetics Corporation that was cleared by the FDA under K001842 on 9/15/00. Device Description: Nonin'so Model, 7600 non-invasive Regional Oximeter System con…
Somanetics Corp.2000—

Also cleared against K001842: 9 other devices →

What descends from it? (54)

See all 54

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102715Regional OximeterNonin Medical, Inc.201053

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 23, 2009Not classifiedZ-0458-2010Device DesignA 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…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K102715 (Nonin Medical, Inc., 2010) has gone furthest, with 53 descendants of its own.
  • 9 other devices also cite its predicate K001842.

How does its category compare?

All MUD devices

MUD Oximeter, Tissue Saturation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MUD

2in 2025

2008: 42009: 42010: 42011: 22012: 62013: 22014: 52015: 32016: 42017: 32018: 32019: 72020: 22021: 22022: 22023: 22024: 52025: 22026 (partial year): 1
2007high 7 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUD

124in 2024

2008: 72 days median2009: 96 days median2010: 59 days median2012: 211 days median2014: 109 days median2015: 107 days median2016: 167 days median2017: 249 days median2018: 128 days median2019: 88 days median2024: 124 days median
2007high 249 (2017) · low 59 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MUD

1in 2023

2009: 12022: 22023: 12026 (partial year): 1
2007high 2 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MUD

131in 2025

2008: 22009: 72010: 12011: 22012: 32013: 82014: 42016: 92017: 242018: 382019: 1072020: 502021: 272022: 522023: 732024: 1402025: 131
2007high 140 (2024) · low 0 (2007)2025

MAUDE reports naming product code MUD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
200847202
200949617
201045901
20112—02
2012621103
20132—08
2014510904
2015310700
2016416709
20173249024
20183128038
20197880107
20202—050
20212—027
20222—252
20232—173
202451240140
20252—0131
20261—1—

What is it indicated for?

Nonin's stand-alone non-invasive Model 7600 Regional Oximeter System is intended for use as an adjunct monitor of trends in regional hemoglobin oxygen saturation of blood underneath the sensor. It is intended for spot-checking or continuous monitoring of adult or pediatric patients weighing greater than 88 pounds (40 kilograms). It is intended for use in environments including the operating room, surgical recovery, critical care, emergency room, long-term care and mobile environments.

Indications for use as stated in the FDA summary.

Also cleared against K001842

9 other devices cite the same predicate.

  • K111007Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center Reprocessed Oximax…Midwest Reprocessing Center, LLC · 2011
  • K100523Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model HHS-Safb-SM…Hygia Health Services, Inc. · 2010
  • K091452Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
  • K083892Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
  • K073036Fore-Sight, MC-2000 SeriesCas Medical Systems, Inc. · 2008
  • K061960Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006

More from Nonin Medical, Inc.

50 FDA decisions under this applicant name. See the company

  • K211498Nonin OTC Pulse Oximeter Model 3250Nonin Medical, Inc. · 2024
  • K192900H500 Multi-Sensing Oximetry SystemNonin Medical, Inc. · 2020
  • K191403Pulse OximeterNonin Medical, Inc. · 2019
  • K190560SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient InterfaceNonin Medical, Inc. · 2019
  • K172625Reusable, Finger Clip Nonin Medical CO-Met Oximetry SensorNonin Medical, Inc. · 2018

Recent decisions in MUD

The MUD category page

  • K254129Spectrum-2Neko Health AB · 2026
  • K243324Masimo O3 Regional OximeterMasimo Corporation · 2025
  • K250519Lap.Ox™ Laparoscopic Tissue OximeterVioptix, Inc. · 2025
  • K240596Cerebral Autoregulation Index (CAI) AlgorithmEdwards Lifesciences · 2024
  • K241393ODI-TechOdi Medical AS · 2024

https://510kreport.com/device/K090807 · printed Nov 3, 2026

Cite this page

510(k) Report. “K090807: Regional Oximeter System, Model 7600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090807

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026