510(k) Report

510(k) · Cleared

Cleared

Actiware-PLMS

K011430510(k) SpecialCleared May 31, 200122-day reviewClass II21 CFR 882.1400

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

Mini-Mitter Co., Inc. · GWQ Full-Montage Standard Electroencephalograph

Cleared on May 31, 2001 after a 22-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 37 later devices descend from it.

Decided
May 31, 2001
Review
22 days
Class
Class II
Product code
GWQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2013: 2 descendants cleared2023: 4 descendants cleared2020: 3 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared2022: 4 descendants cleared2018: 2 descendants cleared2017: 1 descendant cleared2025: 6 descendants cleared2019: 2 descendants cleared2024: 6 descendants cleared2021: 2 descendants cleared2026: 2 descendants cleared200020052010201520202025
  1. This deviceK011430 Actiware-PLMSMini-Mitter Co., Inc. · 2001
  2. Descendant · cites it directly · 36 of its ownK060919 ActicalRespironics, Inc. · 2006 · Recalled
  3. Descendant · 2 generations on · 35 of its ownK122223 New: Intellivue CL Respiration Pod New: Specialized Assessory…Philips Medizin Systeme Boeblingen GmbH · 2013
  4. Descendant · 3 generations on · 24 of its ownK151736 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015
  5. Descendant · 4 generations on · 23 of its ownK161767 Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017
  6. Descendant · 3 generations on · 20 of its ownK132320 Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

2006: 12013: 22014: 12015: 12017: 12018: 22019: 22020: 32021: 22022: 42023: 42024: 62025: 62026: 2
2006high 6 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 37 · See all
  • K060919ActicalRespironics, Inc. · 2006 · cites it directly36descendants
  • K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment…Philips Medizin Systeme Boeblingen GmbH · 2013 · 2 generations on35descendants
  • K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH · 2015 · 3 generations on24descendants
  • K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH · 2017 · 4 generations on23descendants
  • K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2014 · 3 generations on20descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011430Actiware-PLMSMini-Mitter Co., Inc.2001—
+1K060919ActicalRespironics, Inc.20061
+2K122223New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp…Philips Medizin Systeme Boeblingen GmbH2013—
+3K151736Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boblingen GmbH2015—
+4K161767Philips IntelliVue GuardianSoftwarePhilips Medizin Systeme Boeblingen GmbH2017—
+3K132320Intellivue CL Respiration PodPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201320
201410
201510
201710
201820
201920
202030
202120
202240
202340
202460
202560
202620
FIG. 1 — Lineage of K011430, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GWQ? 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 GWQ device

  1. #1 K260455 New Wave Systemscore 13.7 · 10 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (37)

See all 37

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

NumberDeviceApplicantDecidedDescendants
K060919ActicalRespironics, Inc.200636

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, K060919 (Respironics, Inc., 2006) has gone furthest, with 36 descendants of its own.

How does its category compare?

All GWQ devices

GWQ Full-Montage Standard Electroencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GWQ

1in 2024

2007: 12008: 22010: 32011: 42012: 42013: 22014: 22015: 32016: 32017: 52018: 82020: 62022: 32023: 62024: 12026 (partial year): 2
2007high 8 (2018) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GWQ

137in 2023

2010: 73 days median2011: 220 days median2012: 208 days median2015: 276 days median2016: 50 days median2017: 181 days median2018: 150 days median2020: 216 days median2022: 216 days median2023: 137 days median
2007high 276 (2015) · low 50 (2016)2026

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

Recalls per year · GWQ

1in 2020

2007: 52008: 22009: 12010: 12015: 22019: 22020: 12026 (partial year): 1
2007high 5 (2007) · low 0 (2011)2026

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

Adverse event reports per year · GWQ

13in 2025

2007: 112008: 82009: 72010: 122011: 62012: 92013: 42014: 72015: 132016: 282017: 172018: 152019: 162020: 302021: 202022: 162023: 202024: 172025: 13
2007high 30 (2020) · low 4 (2013)2025

MAUDE reports naming product code GWQ, 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
20071—511
20082—28
20090—17
2010373112
2011422006
2012420809
20132—04
20142—07
20153276213
2016350028
20175181017
20188150015
20190—216
20206216130
20210—020
20223216016
20236137020
20241—017
20250—013
20262—1—

More from Mini-Mitter Co., Inc.

5 FDA decisions under this applicant name. See the company

  • K033534VitalsenseMini-Mitter Co., Inc. · 2004
  • K991045Mini-Logger Series 2000Mini-Mitter Co., Inc. · 1999
  • K991033Actiwatch-ScoreMini-Mitter Co., Inc. · 1999
  • K983533ActiwatchMini-Mitter Co., Inc. · 19993 recalls

Recent decisions in GWQ

The GWQ category page

  • K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U. · 2026
  • K260455New Wave SystemZeto, Inc. · 2026
  • K233403Flexset SystemZeto, Inc. · 2024
  • K231366Neuronaute PlusBioserenity Sas · 2023
  • K221959Q21Neurofield, Inc. · 2023

https://510kreport.com/device/K011430 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011430: Actiware-PLMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011430

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
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026