510(k) · Cleared
ClearedDistaSense (TM) (v1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Life Detection Technologies · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Sep 25, 2026 as substantially equivalent to K223163 (Sleepiz AG, 2023) after a 282-day review. Its family tree reaches back 6 generations to 1983.
- Decided
- Sep 25, 2026
- Review
- 282 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K830295 (1983). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 5 generations backK971813 EMBLAFerguson Medical · 1998
- 4 generations backK070375 Earlysense ES-16 SystemEarlysense, Ltd. · 2007
- 3 generations backK082626 PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009
- 2 generations backK202464 Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. · 2021
- 1 generation backK223163 Sleepiz One+Sleepiz AG · 2023
- This deviceK254058 DistaSense (TM) (v1)Life Detection Technologies · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −5 | K971813 | EMBLA | Ferguson Medical | 1998 | — |
| −4 | K070375 | Earlysense ES-16 System | Earlysense, Ltd. | 2007 | — |
| −3 | K082626 | PAM 3000 | Wireless 2000 RF & Uwb Technologies, Ltd. | 2009 | — |
| −2 | K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | 2021 | — |
| −1 | K223163 | Sleepiz One+ | Sleepiz AG | 2023 | — |
| 0 (this device) | K254058 | DistaSense (TM) (v1) | Life Detection Technologies | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 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 DRT? 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 DRT device
- #1 K252676 The Circadia C300 System (C300)score 15.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K223163 | Sleepiz One+Summary page 5…70.2300 / 868.2375 Product Codes DRT, BZQ 3. Legally Marketed Devices: 21 CFR 807.92(a)(3) Predicate Number K223163 Predicate Trade Name Sleepiz One+ Product Code DRT, BZQ 4. Device Desc… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 43 years and passes through 7 companies; a new generation was cleared every 9.8 years on median.
- 1 of the 20 ancestors has a recall of any class.
- 1 other device also cites its predicate K223163.
How does its category compare?
All DRT devicesDRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · DRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRT
228in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRT
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRT
40in 2025
MAUDE reports naming product code DRT, 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 | 1 | — | 0 | 113 |
| 2008 | 1 | — | 0 | 99 |
| 2009 | 6 | 70 | 0 | 118 |
| 2010 | 3 | 44 | 0 | 63 |
| 2011 | 3 | 149 | 1 | 36 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 26 |
| 2015 | 1 | — | 0 | 48 |
| 2016 | 1 | — | 0 | 55 |
| 2017 | 1 | — | 0 | 159 |
| 2018 | 1 | — | 0 | 224 |
| 2019 | 1 | — | 0 | 447 |
| 2020 | 0 | — | 0 | 50 |
| 2021 | 2 | — | 1 | 85 |
| 2022 | 1 | — | 0 | 35 |
| 2023 | 1 | — | 0 | 47 |
| 2024 | 3 | 228 | 1 | 29 |
| 2025 | 1 | — | 0 | 40 |
| 2026 | 5 | 120 | 0 | — |
What is it indicated for?
The DistaSense(TM) System is a contactless medical device intended to measure heart rate and respiration rate in healthy adult patients, at rest or during sleep (in a non-motion condition) the DistaSense(TM) System is intended to be used by healthcare professionals, caregivers, and patients, with recordings performed in either a clinical setting or in a home environment. The DistaSense(TM) web application is intended for use by healthcare professionals only. This device is not indicated for active patient monitoring, rather, it is intended for retrospective data review in healthy patients. The device is not indicated for use in pregnant women or patients with active implantable devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254058 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254058: DistaSense (TM) (v1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254058
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026