510(k) · Cleared

Cleared

PLM Sensor, Model PLM1

K940014510(k) TraditionalCleared Nov 10, 1994310-day reviewClass II21 CFR 868.2375

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

Pro-Tech, Inc. · BZQ Monitor, Breathing Frequency

Cleared on Nov 10, 1994 after a 310-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 103 later devices descend from it.

Decided: Nov 10, 1994
Review: 310 days
Class: Class II
Product code: BZQ
Recalls: None
Predicates: 0

103 later devices descend from it, 2 citing it directly.

This deviceK940014 PLM Sensor, Model PLM1Pro-Tech, Inc. · 1994
Descendant · cites it directly · 100 of its ownK040605 Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and…Dymedix, Inc. · 2004
Descendant · 2 generations on · 99 of its ownK061993 Equivital, Model EQ-01Hidalgo Limited · 2006
Descendant · 2 generations on · 71 of its ownK113054 EquivitalHidalgo Limited · 2012
Descendant · 3 generations on · 70 of its ownK141167 Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay…Vitalconnect, Inc. · 2014
Descendant · 4 generations on · 43 of its ownK152139 Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015

Showing 5 of 103 descendants. See all descendants

Descendants cleared per year

2004high 15 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 103 · See all

K040605Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix Reusable Limb…Dymedix, Inc. · 2004 · cites it directly100descendants
K061993Equivital, Model EQ-01Hidalgo Limited · 2006 · 2 generations on99descendants
K113054EquivitalHidalgo Limited · 2012 · 2 generations on71descendants
K141167Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software Library and…Vitalconnect, Inc. · 2014 · 3 generations on70descendants
K152139Vital Connect Platform, HealthPatch MD, VitalPatchVitalconnect, Inc. · 2015 · 4 generations on43descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K940014	PLM Sensor, Model PLM1	Pro-Tech, Inc.	1994	—
+1	K040605	Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix…	Dymedix, Inc.	2004	—
+2	K061993	Equivital, Model EQ-01	Hidalgo Limited	2006	—
+2	K113054	Equivital	Hidalgo Limited	2012	—
+3	K141167	Vitalconnect Platform (Consisting of Vitalconnect Sensor, Relay Software…	Vitalconnect, Inc.	2014	—
+4	K152139	Vital Connect Platform, HealthPatch MD, VitalPatch	Vitalconnect, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	1	0
2007	1	0
2008	1	0
2010	1	0
2011	1	0
2012	2	0
2013	2	0
2014	1	0
2015	3	0
2016	2	0
2017	5	0
2018	5	0
2019	9	0
2020	8	0
2021	4	0
2022	8	0
2023	13	0
2024	12	0
2025	15	0
2026	8	0

FIG. 1 — Lineage of K940014, 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 BZQ? 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 BZQ device

#1 K251326 Respiration Rate algorithmscore 20.2 · 30 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (103)

See all 103

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040605	Dymedix Reusable Respiratory Effort Belt Sensor, Model 6015 and Dymedix Reusable Limb…	Dymedix, Inc.	2004	100
K062883	Gereonics Ultra-Piezo Limb Movement Sensor	Gereonics, Inc.	2007	1

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, K040605 (Dymedix, Inc., 2004) has gone furthest, with 100 descendants of its own.

How does its category compare?

All BZQ devices

BZQ Monitor, Breathing Frequency: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BZQ

7in 2025

2007high 7 (2025) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BZQ

255in 2025

2007high 261 (2013) · low 121 (2009)2026

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

Recalls per year · BZQ

1in 2010

2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · BZQ

2in 2022

2007high 13 (2019) · low 0 (2008)2025

MAUDE reports naming product code BZQ, 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	7
2008	1	—	0	0
2009	3	121	0	1
2010	2	—	1	1
2011	1	—	0	0
2012	2	—	0	3
2013	3	261	0	0
2014	2	—	0	0
2015	0	—	0	0
2016	2	—	0	0
2017	0	—	0	11
2018	3	198	0	10
2019	1	—	0	13
2020	2	—	0	10
2021	2	—	0	1
2022	3	198	0	2
2023	1	—	0	0
2024	1	—	0	0
2025	7	255	0	0
2026	2	—	0	—

https://510kreport.com/device/K940014 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940014: PLM Sensor, Model PLM1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940014

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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