510(k) · Cleared
ClearedLifeshirt System with Vivologic Analysis Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivometrics, Inc. · DQK Computer, Diagnostic, Programmable
Cleared on Apr 12, 2002 as substantially equivalent to K942852 (Non-Invasive Monitoring Systems, Inc., 1996) and 1 other predicate after a 298-day review. Its family tree reaches back 1 generation to 1996. 25 later devices descend from it.
- Decided
- Apr 12, 2002
- Review
- 298 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942852 (1996). 2 ancestors in all. 25 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK942852 Respitrace PTNon-Invasive Monitoring Systems, Inc. · 1996
- This deviceK011903 Lifeshirt System with Vivologic Analysis SoftwareVivometrics, Inc. · 2002
- Descendant · cites it directly · 23 of its ownK070375 Earlysense ES-16 SystemEarlysense, Ltd. · 2007
- Descendant · 2 generations on · 21 of its ownK082626 PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009
- Descendant · 2 generations on · 11 of its ownK082465 EveronEarlysense, Ltd. · 2009
- Descendant · 3 generations on · 10 of its ownK092062 Everon 1.0Earlysense, Ltd. · 2010
- Descendant · 3 generations on · 9 of its ownK202464 Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. · 2021
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K070375Earlysense ES-16 SystemEarlysense, Ltd. · 2007 · cites it directly23descendants
- K082626PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009 · 2 generations on21descendants
- K082465EveronEarlysense, Ltd. · 2009 · 2 generations on11descendants
- K092062Everon 1.0Earlysense, Ltd. · 2010 · 3 generations on10descendants
- K202464Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. · 2021 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942852 | Respitrace PT | Non-Invasive Monitoring Systems, Inc. | 1996 | — |
| 0 (this device) | K011903 | Lifeshirt System with Vivologic Analysis Software | Vivometrics, Inc. | 2002 | — |
| +1 | K070375 | Earlysense ES-16 System | Earlysense, Ltd. | 2007 | — |
| +2 | K082626 | PAM 3000 | Wireless 2000 RF & Uwb Technologies, Ltd. | 2009 | — |
| +2 | K082465 | Everon | Earlysense, Ltd. | 2009 | — |
| +3 | K092062 | Everon 1.0 | Earlysense, Ltd. | 2010 | — |
| +3 | K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 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 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K942852 | Respitrace PTSummary page 1…name: Ambulatory Patient Monitor Classification name: Class II, Programmable Diagnostic Computer, 21 CFR 870.1425 Substantial equivalence claimed to: 1. RespiTrace PT, K942852, Non-Invasive Monitoring Systems, Inc. 2. RespiEvents 4.2, K001369, Non-Invasive Monitoring Systems, Inc. Description: The Life… | 1996 |
| * | K001369 | Respievents, Version 4.2Summary page 1…ogrammable Diagnostic Computer, 21 CFR 870.1425 Substantial equivalence claimed to: 1. RespiTrace PT, K942852, Non-Invasive Monitoring Systems, Inc. 2. RespiEvents 4.2, K001369, Non-Invasive Monitoring Systems, Inc. Description: The LifeShirt is a noninvasive ambulatory monitoring device that continuous… | 2000 |
What descends from it? (25)
See all 253 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All DQK devicesDQK 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
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 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 | — |
What is it indicated for?
The Life Shirt system is intended for use by one adult during daily activities of living and sleep, for the purpose of recording physiological data for later analysis by a physician. Respiration, ECG, pulse oximetry, blood pressure, and body position data may be collected. The system 1s intended to provide analysis of breathing patterns as an aid in classifying apneas as well as displaying heart rate changes from electrocardiographic waveforms in the…
Read the full statement (122 words)
The Life Shirt system is intended for use by one adult during daily activities of living and sleep, for the purpose of recording physiological data for later analysis by a physician. Respiration, ECG, pulse oximetry, blood pressure, and body position data may be collected. The system 1s intended to provide analysis of breathing patterns as an aid in classifying apneas as well as displaying heart rate changes from electrocardiographic waveforms in the wake and sleeping states as well as activities of daily living. Applications may include pharmaceutical studies in which respiratory informatiozi is a useful indicator, or the general healthcare market where patients may be monitored at home and the data provided to their physicians as an aid to diagnosis and treatment.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011903 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011903: Lifeshirt System with Vivologic Analysis Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011903
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026