510(k) · Cleared
ClearedSleepiz One+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sleepiz AG · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Aug 18, 2023 as substantially equivalent to K202464 (Xandar Kardian, Inc., 2021) after a 315-day review. Its family tree reaches back 5 generations to 1983. 3 later devices descend from it.
- Decided
- Aug 18, 2023
- Review
- 315 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K830295 (1983). 19 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 4 generations backK971813 EMBLAFerguson Medical · 1998
- 3 generations backK070375 Earlysense ES-16 SystemEarlysense, Ltd. · 2007
- 2 generations backK082626 PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009
- 1 generation backK202464 Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. · 2021
- This deviceK223163 Sleepiz One+Sleepiz AG · 2023
- Descendant · cites it directly · 1 of its ownK251364 Sleepiz One+ (2.5)Sleepiz AG · 2025
- Descendant · cites it directly · 0 of its ownK254058 DistaSense (TM) (v1)Life Detection Technologies · 2026
- Descendant · 2 generations on · 0 of its ownK253388 Sleepiz One+ (Model 2.5)Sleepiz AG · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −4 | K971813 | EMBLA | Ferguson Medical | 1998 | — |
| −3 | K070375 | Earlysense ES-16 System | Earlysense, Ltd. | 2007 | — |
| −2 | K082626 | PAM 3000 | Wireless 2000 RF & Uwb Technologies, Ltd. | 2009 | — |
| −1 | K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | 2021 | — |
| 0 (this device) | K223163 | Sleepiz One+ | Sleepiz AG | 2023 | — |
| +1 | K251364 | Sleepiz One+ (2.5) | Sleepiz AG | 2025 | — |
| +1 | K254058 | DistaSense (TM) (v1) | Life Detection Technologies | 2026 | — |
| +2 | K253388 | Sleepiz One+ (Model 2.5) | Sleepiz AG | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 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.
What descends from it? (3)
2 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?
- The line of descent spans 40 years and passes through 6 companies; a new generation was cleared every 9.8 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K251364 (Sleepiz AG, 2025) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K202464.
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. 2023, 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?
Sleepiz One+ is a contactless medical device intended to measure heart rate and respiration rate in adult patients, at rest or during sleep (in non-motion condition). The Sleepiz One+ hardware unit is intended to be used by a healthcare professional when the recordings are performed in a clinical setting, or by patients or their caregivers when the recordings are performed in a home environment. The Sleepiz One+ web application is intended for use by…
Read the full statement (131 words)
Sleepiz One+ is a contactless medical device intended to measure heart rate and respiration rate in adult patients, at rest or during sleep (in non-motion condition).
The Sleepiz One+ hardware unit is intended to be used by a healthcare professional when the recordings are performed in a clinical setting, or by patients or their caregivers when the recordings are performed in a home environment.
The Sleepiz One+ web application is intended for use by healthcare professionals.
Sleepiz One+ device can also detect the presence of patients and their body movements at rest or during sleep.
This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations. It is not indicated for use on pregnant women or patients with active implantable devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223163 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223163: Sleepiz One+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223163
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026