510(k) · Cleared

Cleared

Respievents, Version 4.2

K001369510(k) TraditionalCleared Jul 26, 200086-day reviewClass II21 CFR 870.1425

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

Non-Invasive Monitoring Systems, Inc. · DQK Computer, Diagnostic, Programmable

Cleared on Jul 26, 2000 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 28 later devices descend from it.

Decided: Jul 26, 2000
Review: 86 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 0

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

This deviceK001369 Respievents, Version 4.2Non-Invasive Monitoring Systems, Inc. · 2000
Descendant · cites it directly · 25 of its ownK011903 Lifeshirt System with Vivologic Analysis SoftwareVivometrics, Inc. · 2002
Descendant · 2 generations on · 23 of its ownK070375 Earlysense ES-16 SystemEarlysense, Ltd. · 2007
Descendant · 3 generations on · 21 of its ownK082626 PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009
Descendant · 3 generations on · 11 of its ownK082465 EveronEarlysense, Ltd. · 2009
Descendant · 4 generations on · 10 of its ownK092062 Everon 1.0Earlysense, Ltd. · 2010

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2001high 5 (2026) · low 0 (2003)2026

Most influential descendants

Showing 5 of 28 · See all

K011903Lifeshirt System with Vivologic Analysis SoftwareVivometrics, Inc. · 2002 · cites it directly25descendants
K070375Earlysense ES-16 SystemEarlysense, Ltd. · 2007 · 2 generations on23descendants
K082626PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009 · 3 generations on21descendants
K082465EveronEarlysense, Ltd. · 2009 · 3 generations on11descendants
K092062Everon 1.0Earlysense, Ltd. · 2010 · 4 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K001369	Respievents, Version 4.2	Non-Invasive Monitoring Systems, Inc.	2000	—
+1	K011903	Lifeshirt System with Vivologic Analysis Software	Vivometrics, Inc.	2002	—
+2	K070375	Earlysense ES-16 System	Earlysense, Ltd.	2007	—
+3	K082626	PAM 3000	Wireless 2000 RF & Uwb Technologies, Ltd.	2009	—
+3	K082465	Everon	Earlysense, Ltd.	2009	—
+4	K092062	Everon 1.0	Earlysense, Ltd.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2007	1	0
2009	2	0
2010	1	0
2012	1	0
2013	2	0
2014	1	0
2016	2	0
2018	2	0
2019	1	0
2021	2	0
2022	2	0
2023	1	0
2024	2	0
2025	1	0
2026	5	0

FIG. 1 — Lineage of K001369, 2000–2026Source: 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 DQK? 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 DQK device

#1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K011903	Lifeshirt System with Vivologic Analysis Software	Vivometrics, Inc.	2002	25
K012020	Respievents Software IS Event Data Processing Sofware for a PC	Non-Invasive Monitoring Systems, Inc.	2001	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, K011903 (Vivometrics, Inc., 2002) has gone furthest, with 25 descendants of its own.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007high 190 (2016) · low 64 (2010)2026

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

Recalls per year · DQK

1in 2025

2007high 24 (2024) · low 0 (2016)2026

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

Adverse event reports per year · DQK

433in 2025

2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, 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	13	83	4	18
2008	4	70	1	34
2009	12	93	2	40
2010	9	64	3	49
2011	12	69	2	55
2012	7	74	3	129
2013	13	68	1	180
2014	9	90	4	115
2015	7	125	2	131
2016	15	190	0	340
2017	7	146	2	252
2018	14	150	6	261
2019	15	113	1	218
2020	16	123	1	215
2021	16	132	1	351
2022	19	136	2	319
2023	21	133	2	340
2024	13	100	24	557
2025	22	95	1	433
2026	23	151	2	—

https://510kreport.com/device/K001369 · printed Nov 5, 2026

Cite this page

510(k) Report. “K001369: Respievents, Version 4.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001369

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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