510(k) · Cleared

Cleared

Spectrum M2 Monitor

K062468510(k) TraditionalCleared Sep 13, 200620-day reviewClass II21 CFR 870.4330

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

Spectrum Medical, Llp · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Cleared on Sep 13, 2006 as substantially equivalent to K931968 (3M Health Care, Ltd., 1993) after a 20-day review. Its family tree reaches back 1 generation to 1993. 2 of the 17 devices in its family, counting itself, have a Class I recall. 15 later devices descend from it.

Decided: Sep 13, 2006
Review: 20 days
Class: Class II
Product code: DRY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K931968 (1993). 15 later devices descend from it, 1 citing it directly. 2 of the 17 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK931968 Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio3M Health Care, Ltd. · 1993
This deviceK062468 Spectrum M2 MonitorSpectrum Medical, Llp · 2006
Descendant · cites it directly · 14 of its ownK071725 M2 MonitorSpectrum Medical, Ltd. · 2007
Descendant · 2 generations on · 10 of its ownK072131 M3 MonitorSpectrum Medical, Ltd. · 2007
Descendant · 3 generations on · 5 of its ownK091908 M3 MonitorSpectrum Medical, Ltd. · 2009 · Recalled
Descendant · 4 generations on · 4 of its ownK110957 M4 MonitorSpectrum Medical, Llp · 2011
Descendant · 5 generations on · 3 of its ownK173591 Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2007high 3 (2018) · low 0 (2008)2026

Class I recalls in this family

K102726 Cardiohelp System4 generations on · 2011
K133598 Cardiohelp System5 generations on · 2014

Most influential descendants

Showing 5 of 15 · See all

K071725M2 MonitorSpectrum Medical, Ltd. · 2007 · cites it directly14descendants
K072131M3 MonitorSpectrum Medical, Ltd. · 2007 · 2 generations on10descendants
K091908M3 MonitorSpectrum Medical, Ltd. · 2009 · 3 generations on5descendants
K110957M4 MonitorSpectrum Medical, Llp · 2011 · 4 generations on4descendants
K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018 · 5 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K931968	Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio	3M Health Care, Ltd.	1993	—
0 (this device)	K062468	Spectrum M2 Monitor	Spectrum Medical, Llp	2006	—
+1	K071725	M2 Monitor	Spectrum Medical, Ltd.	2007	—
+2	K072131	M3 Monitor	Spectrum Medical, Ltd.	2007	—
+3	K091908	M3 Monitor	Spectrum Medical, Ltd.	2009	1
+4	K110957	M4 Monitor	Spectrum Medical, Llp	2011	—
+5	K173591	Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas	Spectrum Medical, Ltd.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0
2009	2	0
2011	2	1
2013	1	0
2014	1	1
2017	1	0
2018	3	0
2020	2	0
2021	1	0

FIG. 1 — Lineage of K062468, 1993–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

2 devices in this family have a Class I recall. 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 DRY device

#1 K234065 CDI OneView Monitoring Systemscore 5.5 · 2 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K931968	Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio Summary page 1 …s Monitor Trade Name: Spectrum M2 Monitor Classification Name: Monitor, Blood-Gas, On-Line, Cardiopulmonnary Bypass 21 CFR 870.4330, Product code: DRY Predicate Device: K931968 3M Health Care, Ltd CDI 100 Extracorporeal Hematocrit / Oxygen Monitoring Device Description of Proposed Device: The Spectrum M2…	3M Health Care, Ltd.	1993	—

Also cleared against K931968: 1 other device →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K071725	M2 Monitor	Spectrum Medical, Ltd.	2007	14

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 4 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K071725 (Spectrum Medical, Ltd., 2007) has gone furthest, with 14 descendants of its own.
1 other device also cites its predicate K931968.

How does its category compare?

All DRY devices

DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRY

1in 2024

2007high 3 (2018) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRY

88in 2018

2007high 88 (2018)2026

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

Recalls per year · DRY

1in 2020

2007high 14 (2011) · low 0 (2007)2026

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

Adverse event reports per year · DRY

134in 2025

2007high 2,268 (2011) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	0	0
2008	0	—	1	1
2009	2	—	0	2
2010	0	—	6	1,070
2011	2	—	14	2,268
2012	1	—	5	167
2013	0	—	0	157
2014	2	—	0	156
2015	0	—	1	231
2016	0	—	0	240
2017	1	—	0	61
2018	3	88	0	165
2019	0	—	0	63
2020	1	—	1	35
2021	1	—	0	42
2022	0	—	0	37
2023	0	—	0	41
2024	1	—	0	72
2025	0	—	0	134
2026	0	—	0	—

What is it indicated for?

The M2 Monitor is intended as a device for the non-invasive continuous monitoring of oxygen saturation of the blood in an extracorporeal circuit. The device provides monitoring information to trained clinicians and can be configured by them to alarm for set saturation levels.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062468 · printed Nov 5, 2026

Cite this page

510(k) Report. “K062468: Spectrum M2 Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062468

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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