510(k) · Cleared
ClearedVital Sign Monitoring Sensor (Model :XK300)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xandar Kardian, Inc. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Apr 26, 2021 as substantially equivalent to K082626 (Wireless 2000 RF & Uwb Technologies, Ltd., 2009) after a 242-day review. Its family tree reaches back 4 generations to 1983. 9 later devices descend from it.
- Decided
- Apr 26, 2021
- Review
- 242 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K830295 (1983). 18 ancestors in all. 9 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 3 generations backK971813 EMBLAFerguson Medical · 1998
- 2 generations backK070375 Earlysense ES-16 SystemEarlysense, Ltd. · 2007
- 1 generation backK082626 PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009
- This deviceK202464 Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. · 2021
- Descendant · cites it directly · 3 of its ownK223163 Sleepiz One+Sleepiz AG · 2023
- Descendant · cites it directly · 2 of its ownK234003 The Circadia C200 SystemCircadia Technologies, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK252676 The Circadia C300 System (C300)Circadia Health, Inc. · 2026
- Descendant · 2 generations on · 1 of its ownK251364 Sleepiz One+ (2.5)Sleepiz AG · 2025
- Descendant · cites it directly · 1 of its ownK212143 Neteera 130H/131H Vital Sign Monitoring SensorNeteera Technologies, Ltd. · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K223163Sleepiz One+Sleepiz AG · 2023 · cites it directly3descendants
- K234003The Circadia C200 SystemCircadia Technologies, Ltd. · 2024 · cites it directly2descendants
- K252676The Circadia C300 System (C300)Circadia Health, Inc. · 2026 · 2 generations on1descendant
- K251364Sleepiz One+ (2.5)Sleepiz AG · 2025 · 2 generations on1descendant
- K212143Neteera 130H/131H Vital Sign Monitoring SensorNeteera Technologies, Ltd. · 2022 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −3 | K971813 | EMBLA | Ferguson Medical | 1998 | — |
| −2 | K070375 | Earlysense ES-16 System | Earlysense, Ltd. | 2007 | — |
| −1 | K082626 | PAM 3000 | Wireless 2000 RF & Uwb Technologies, Ltd. | 2009 | — |
| 0 (this device) | K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | 2021 | — |
| +1 | K223163 | Sleepiz One+ | Sleepiz AG | 2023 | — |
| +1 | K234003 | The Circadia C200 System | Circadia Technologies, Ltd. | 2024 | — |
| +2 | K252676 | The Circadia C300 System (C300) | Circadia Health, Inc. | 2026 | — |
| +2 | K251364 | Sleepiz One+ (2.5) | Sleepiz AG | 2025 | — |
| +1 | K212143 | Neteera 130H/131H Vital Sign Monitoring Sensor | Neteera Technologies, Ltd. | 2022 | — |
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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K082626 | PAM 3000Summary page 4…and Respiration Rate Monitor Regulatory Class: II Product Code: DRT & BZQ 4. Predicate Device Trade Name: Patient Assessment Monitor (PAMTM3000) 510(k) Number: K082626 Classification Name: Monitor, Cardiac (incl Cardiotachometer & Rate Alarm) & Monitor, Breathing Frequency Regulation Number… | 2009 |
What descends from it? (9)
3 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 38 years and passes through 5 companies; a new generation was cleared every 12.3 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K223163 (Sleepiz AG, 2023) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K082626.
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. 2021, 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 Vital Sign Monitoring Sensor (Model XK300) is intended to measure heart rate and respiration rate in adult patients
in a general care hospital environment including nursing homes. The Vital Sign Monitoring Sensor can be used for home
healthcare for data collection to inform patient care but not to acutely treat a patient. XK300 monitors presence or absence
of a patient in detection area of within 7 meters. The XK30 also monitors the length of continuous patient motion or
absence of patient motion.
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/K202464 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202464: Vital Sign Monitoring Sensor (Model :XK300).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202464
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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