510(k) Report

510(k) · Cleared

Cleared

Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center Reprocessed Oximax Sensors; Midwest RE

K111007510(k) TraditionalCleared Jun 8, 201158-day reviewClass II21 CFR 870.2700

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

Midwest Reprocessing Center, LLC · NMD Oximeter, Tissue Saturation, Reprocessed

Cleared on Jun 8, 2011 as substantially equivalent to K082327 (Somanetics Corp., 2009) and 5 other predicates after a 58-day review. Its family tree reaches back 4 generations to 2000.

Decided
Jun 8, 2011
Review
58 days
Class
Class II
Product code
NMD
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K001842 (2000). 8 ancestors in all, the oldest K863784 (1986). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 1 other ancestor1988: 1 other ancestor1986: 1 other ancestorK001842 · Adult/Pediatric Cerebral Oximeter, Model Invos 5100 · Somanetics Corp. · 2000K051274 · Invos System · Somanetics Corp. · 2005K080769 · Invos Cerebral/Somatic Oximeter System, Model 5100C · Somanetics Corp. · 2008K082327 · Invos Cerebral/Somatic Oximeter System, Model: 5100C · Somanetics Corp. · 2009198519901995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors K082327 · Invos Cerebral/Somatic Oximeter System, Model: 5100C · Somanetics Corp. · 2009K080769 · Invos Cerebral/Somatic Oximeter System, Model 5100C · Somanetics Corp. · 2008K051274 · Invos System · Somanetics Corp. · 2005K001842 · Adult/Pediatric Cerebral Oximeter, Model Invos 5100 · Somanetics Corp. · 20000
  1. Root · 4 generations backK001842 Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp. · 2000
  2. 3 generations backK051274 Invos SystemSomanetics Corp. · 2005
  3. 2 generations backK080769 Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp. · 2008
  4. 1 generation backK082327 Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp. · 2009
  5. This deviceK111007 Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest…Midwest Reprocessing Center, LLC · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K001842Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp.2000—
−3K051274Invos SystemSomanetics Corp.2005—
−2K080769Invos Cerebral/Somatic Oximeter System, Model 5100CSomanetics Corp.2008—
−1K082327Invos Cerebral/Somatic Oximeter System, Model: 5100CSomanetics Corp.2009—
0 (this device)K111007Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing…Midwest Reprocessing Center, LLC2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198810
199610
199710
FIG. 1 — Lineage of K111007, 2000–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (6)

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
*K082327Invos Cerebral/Somatic Oximeter System, Model: 5100C
Summary page 1
…Corresponding Somanetics oximetry sensors legally marketed under various 5 10(k) premarket notifications: Somanetics Corp. K082327 Somanetics Corp. .K080769 Somanetics Corp. K05 1274 Somanetics Corp.…
Somanetics Corp.2009—
*K080769Invos Cerebral/Somatic Oximeter System, Model 5100C
Summary page 1
…y sensors legally marketed under various 5 10(k) premarket notifications: Somanetics Corp. K082327 Somanetics Corp. .K080769 Somanetics Corp. K05 1274 Somanetics Corp. KOO01842…
Somanetics Corp.2008—
*K051274Invos System
Summary page 1
…ket notifications: Somanetics Corp. K082327 Somanetics Corp. .K080769 Somanetics Corp. K05 1274 Somanetics Corp. KOO01842 Somanetics Corp. K97 1628…
Somanetics Corp.2005—
*K001842Adult/Pediatric Cerebral Oximeter, Model Invos 5100Somanetics Corp.2000—
*K971628Somanetics Invos 3100A Cerebral Oximeter (Invos)
Summary page 1
…Somanetics Corp. K05 1274 Somanetics Corp. KOO01842 Somanetics Corp. K97 1628 Somanetics Corp. K960614…
Somanetics Corp.1997—
*K960614Somanetics Invos 3100A Cerebral Oximeter (Invos)
Summary page 1
…Somanetics Corp. KOO01842 Somanetics Corp. K97 1628 Somanetics Corp. K960614 3-2 4. Device De…
Somanetics Corp.1996—

Also cleared against K082327: 9 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
  • None of the 8 ancestors has a recall.
  • 9 other devices also cite its predicate K082327.

How does its category compare?

All NMD devices

NMD Oximeter, Tissue Saturation, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · NMD

1in 2011

2010: 12011: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NMD

Too few NMD 510(k)s in any year since 2007 to give a median.

Recalls per year · NMD

No recall names NMD since 2007.

Adverse event reports per year · NMD

2in 2024

2024: 2
2007high 2 (2024) · low 0 (2007)2025

MAUDE reports naming product code NMD, 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
20080—00
20090—00
20101—00
20111—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—02
20250—00
20260—0—

What is it indicated for?

The Midwest Reprocessing Center (MRC) Reprocessed Cerebral-Somatic Oximetry Sensors are indicated for use when continuous noninvasive trending of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor is required.

Indications for use as stated in the FDA summary.

Also cleared against K082327

9 other devices cite the same predicate.

  • K211561INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also…Covidien, LLC · 20211 recall
  • K182868INVOS PM7100 Patient Monitor, INVOS Adult rSO2 SensorCovidien, LLC · 20191 recall
  • K182242VO200 – NeurOs Cerebral Oximetry SystemMespere Lifesciences, Inc. · 2018
  • K162603Masimo O3 Regional Oximeter SystemMasimo Corporation · 2017
  • K143219Niro-200NXHamamatsu Photonics K.K. · 2015
  • K094030Fore-Sight Absolute Cerebral and Somatic Oximeter, MC 2000 Series, Models MC2000, MC2010, MC2020, MC2030Cas Medical Systems, Inc. · 2010

More from Midwest Reprocessing Center, LLC

4 FDA decisions under this applicant name. See the company

  • K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC · 2010
  • K101702Midwest Reprocessing Center Reprocessed Venodyne Sleeves/Foot CuffsMidwest Reprocessing Center, LLC · 2010
  • K101330Midwest Reprocessing Center Reprocessed SCD Express Sleeves/ Foot Cuffs, Midwest Reprocessing Center…Midwest Reprocessing Center, LLC · 2010

Recent decisions in NMD

The NMD category page

  • K100523Adult Cerebral-Somatic Oximetry Sensor, Pediatric Cerebral-Somatic Oximetry Sensor Model HHS-Safb-SM…Hygia Health Services, Inc. · 2010

https://510kreport.com/device/K111007 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111007: Midwest Reprocessing Center Reprocessed LNCS Sessors; Midwest Reprocessing Center Reprocessed Oximax Sensors; Midwest RE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111007

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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