510(k) Report

510(k) · Cleared

Cleared

Omni-Trak 3150/3155A Series Monitor with Anesthetic Agent, Model 3155A Series

K002030510(k) TraditionalCleared Sep 26, 200085-day reviewClass II21 CFR 870.2300

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

Invivo Research, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Cleared on Sep 26, 2000 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 57 later devices descend from it.

Decided
Sep 26, 2000
Review
85 days
Class
Class II
Product code
MWI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2004: 1 descendant cleared2005: 1 descendant cleared2006: 1 descendant cleared2019: 4 descendants cleared2007: 2 descendants cleared2009: 1 descendant cleared2015: 4 descendants cleared2014: 3 descendants cleared2011: 2 descendants cleared2008: 1 descendant cleared2020: 4 descendants cleared2012: 2 descendants cleared2013: 3 descendants cleared2021: 5 descendants cleared2017: 6 descendants cleared2016: 3 descendants cleared2022: 3 descendants cleared2018: 1 descendant cleared2023: 6 descendants cleared2025: 1 descendant cleared2024: 1 descendant cleared2026: 2 descendants cleared200020052010201520202025
  1. This deviceK002030 Omni-Trak 3150/3155A Series Monitor with Anesthetic Agent, Model…Invivo Research, Inc. · 2000
  2. Descendant · cites it directly · 56 of its ownK041918 Integrated Patient Monitoring SystemInvivo Research, Inc. · 2004
  3. Descendant · 2 generations on · 55 of its ownK050399 Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
  4. Descendant · 2 generations on · 53 of its ownK053462 3160 Mri Patient Monitoring SystemInvivo Corporation · 2006 · Recalled
  5. Descendant · 3 generations on · 40 of its ownK071641 Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient…Medtronic, Inc. · 2007
  6. 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

2004: 12005: 12006: 12007: 22008: 12009: 12011: 22012: 22013: 32014: 32015: 42016: 32017: 62018: 12019: 42020: 42021: 52022: 32023: 62024: 12025: 12026: 2
2004high 6 (2017) · low 0 (2010)2026

Most influential descendants

Showing 5 of 57 · See all
  • K041918Integrated Patient Monitoring SystemInvivo 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002030Omni-Trak 3150/3155A Series Monitor with Anesthetic Agent, Model 3155A SeriesInvivo Research, Inc.2000—
+1K041918Integrated Patient Monitoring SystemInvivo Research, Inc.2004—
+2K050399Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc.2005—
+2K0534623160 Mri Patient Monitoring SystemInvivo Corporation20062
+3K071641Reveal XT; Insertable Cardiac Monitor (Model 9529), Patient Assistant (Model…Medtronic, Inc.2007—
+3K071655Reveal DX Insertable Cardiac Monitor, Reveal Patient Assistant, Model (S)…Medtronic, Inc.2007—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200610
200720
200810
200910
201120
201220
201330
201430
201540
201630
201760
201810
201940
202040
202150
202230
202360
202410
202510
202620
FIG. 1 — Lineage of K002030, 2000–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MWI? 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 MWI device

  1. #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 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?

FDA has not posted a summary or statement for it, 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.

NumberDeviceApplicantDecidedDescendants
K041918Integrated Patient Monitoring SystemInvivo Research, Inc.200456

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, K041918 (Invivo Research, Inc., 2004) has gone furthest, with 56 descendants of its own.

How does its category compare?

All MWI devices

MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MWI

4in 2025

2007: 92008: 92009: 62010: 172011: 112012: 132013: 202014: 162015: 192016: 122017: 132018: 112019: 142020: 82021: 92022: 52023: 82024: 102025: 42026 (partial year): 6
2007high 20 (2013) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MWI

247in 2025

2007: 42 days median2008: 49 days median2009: 112 days median2010: 58 days median2011: 78 days median2012: 104 days median2013: 85 days median2014: 148 days median2015: 127 days median2016: 165 days median2017: 205 days median2018: 217 days median2019: 255 days median2020: 138 days median2021: 161 days median2022: 231 days median2023: 250 days median2024: 202 days median2025: 247 days median2026 (partial year): 239 days median
2007high 255 (2019) · low 42 (2007)2026

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

Recalls per year · MWI

9so far in 2026, the most since 2007

2007: 12008: 12009: 22010: 22011: 32012: 52013: 32014: 62015: 12017: 22019: 42022: 22024: 52026 (partial year): 9
2007high 9 (2026) · low 0 (2016)2026

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

Adverse event reports per year · MWI

182in 2025

2007: 32008: 32009: 202010: 172011: 162012: 312013: 422014: 302015: 312016: 512017: 852018: 1582019: 1692020: 1102021: 1882022: 1682023: 1792024: 1202025: 182
2007high 188 (2021) · low 3 (2007)2025

MAUDE reports naming product code MWI, 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
200794213
200894913
20096112220
20101758217
20111178316
201213104531
20132085342
201416148630
201519127131
201612165051
201713205285
2018112170158
2019142554169
202081380110
202191610188
202252312168
202382500179
2024102025120
202542470182
202662399—

More from Invivo Research, Inc.

14 FDA decisions under this applicant name. See the company

  • K050399Mri Compatible Patient Monitoring System, Model 3160Invivo Research, Inc. · 2005
  • K043354Modular Telemetry System for the Vision Telepak, Model 20701Invivo Research, Inc. · 2005
  • K041918Integrated Patient Monitoring SystemInvivo Research, Inc. · 2004
  • K040915Magnitude 3150M Mri Patient Monitor, Model 3150MInvivo Research, Inc. · 2004
  • K002604Centurion 2000 Central Station Arrhythmia Patient Monitoring SystemInvivo Research, Inc. · 2002

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The MWI category page

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https://510kreport.com/device/K002030 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002030: Omni-Trak 3150/3155A Series Monitor with Anesthetic Agent, Model 3155A Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002030

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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