510(k) · Cleared

Cleared

Luxtron Model 3100/3101/3102 Multichannel

K923189510(k) TraditionalCleared Mar 28, 1994636-day reviewClass II21 CFR 880.2910

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

Luxtron · FLL Continuous Measurement Thermometer

Cleared on Mar 28, 1994 after a 636-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 57 later devices descend from it.

Decided: Mar 28, 1994
Review: 636 days
Class: Class II
Product code: FLL
Recalls: None
Predicates: 0

57 later devices descend from it, 1 citing it directly.

This deviceK923189 Luxtron Model 3100/3101/3102 MultichannelLuxtron · 1994
Descendant · cites it directly · 56 of its ownK040915 Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
Descendant · 2 generations on · 55 of its ownK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
Descendant · 2 generations on · 53 of its ownK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
Descendant · 3 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
Descendant · 3 generations on · 30 of its ownK071655 Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant…Medtronic, Inc. · 2007

Showing 5 of 57 descendants. See all descendants

Descendants cleared per year

2004high 6 (2017) · low 0 (2010)2026

Most influential descendants

Showing 5 of 57 · See all

K040915Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004 · cites it directly56descendants
K050399Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005 · 2 generations on55descendants
K0534623160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · 2 generations on53descendants
K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model 9539)Medtronic, Inc. · 2007 · 3 generations on40descendants
K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S) 9528,9538Medtronic, Inc. · 2007 · 3 generations on30descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K923189	Luxtron Model 3100/3101/3102 Multichannel	Luxtron	1994	—
+1	K040915	Magnitude 3150M Mri Patient Monitor, Model 3150M	Invivo Research, Inc.	2004	—
+2	K050399	Mri Compatible Patient Monitoring System, Model 3160	Invivo Research, Inc.	2005	—
+2	K053462	3160 Mri Patient Monitoring System	Invivo Corporation	2006	2
+3	K071641	Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…	Medtronic, Inc.	2007	—
+3	K071655	Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)…	Medtronic, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	1	0
2007	2	0
2008	1	0
2009	1	0
2011	2	0
2012	2	0
2013	3	0
2014	3	0
2015	4	0
2016	3	0
2017	6	0
2018	1	0
2019	4	0
2020	4	0
2021	5	0
2022	3	0
2023	6	0
2024	1	0
2025	1	0
2026	2	0

FIG. 1 — Lineage of K923189, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in FLL? 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 FLL device

#1 K191829 Microlife Non-Contact Infrared Forehead…score 26.7 · 4 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (57)

See all 57

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

Number	Device	Applicant	Decided	Descendants
K040915	Magnitude 3150M Mri Patient Monitor, Model 3150M	Invivo Research, Inc.	2004	56

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?

Of its descendants, K040915 (Invivo Research, Inc., 2004) has gone furthest, with 56 descendants of its own.

How does its category compare?

All FLL devices

FLL Continuous Measurement Thermometer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FLL

6in 2025

2007high 43 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FLL

131in 2025

2007high 295 (2023) · low 59 (2008)2026

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

Recalls per year · FLL

1in 2025

2007high 5 (2019) · low 0 (2007)2026

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

Adverse event reports per year · FLL

73in 2025

2007high 142 (2022) · low 4 (2007)2025

MAUDE reports naming product code FLL, 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	15	81	0	4
2008	14	59	0	13
2009	13	84	0	9
2010	24	88	0	9
2011	20	113	1	18
2012	17	126	0	26
2013	14	149	0	16
2014	7	199	0	54
2015	3	270	1	53
2016	22	157	0	58
2017	16	174	2	118
2018	35	209	1	51
2019	22	198	5	52
2020	21	194	0	53
2021	43	218	0	115
2022	24	218	0	142
2023	17	295	0	101
2024	13	223	0	118
2025	6	131	1	73
2026	2	—	1	—

https://510kreport.com/device/K923189 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923189: Luxtron Model 3100/3101/3102 Multichannel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923189

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026