510(k) · Cleared
ClearedPAM 3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wireless 2000 RF & Uwb Technologies, Ltd. · DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Cleared on Jan 16, 2009 as substantially equivalent to K070375 (Earlysense, Ltd., 2007) and 1 other predicate after a 129-day review. Its family tree reaches back 3 generations to 1983. 21 later devices descend from it.
- Decided
- Jan 16, 2009
- Review
- 129 days
- Class
- Class II
- Product code
- DRT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K830295 (1983). 17 ancestors in all. 21 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK830295 Medilog 9000 SystemOxford Medilog, Inc. · 1983
- 2 generations backK971813 EMBLAFerguson Medical · 1998
- 1 generation backK070375 Earlysense ES-16 SystemEarlysense, Ltd. · 2007
- This deviceK082626 PAM 3000Wireless 2000 RF & Uwb Technologies, Ltd. · 2009
- Descendant · cites it directly · 10 of its ownK092062 Everon 1.0Earlysense, Ltd. · 2010
- Descendant · cites it directly · 9 of its ownK202464 Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. · 2021
- Descendant · 2 generations on · 9 of its ownK120465 Earlysense (Everon) SystemEarlysense, Ltd. · 2012
- Descendant · 3 generations on · 7 of its ownK131379 EarlysenseEarlysense, Ltd. · 2013
- Descendant · 3 generations on · 6 of its ownK133661 Chair Sensing Unit for Earlysense SystemEarlysense, Ltd. · 2014
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K092062Everon 1.0Earlysense, Ltd. · 2010 · cites it directly10descendants
- K202464Vital Sign Monitoring Sensor (Model :XK300)Xandar Kardian, Inc. · 2021 · cites it directly9descendants
- K120465Earlysense (Everon) SystemEarlysense, Ltd. · 2012 · 2 generations on9descendants
- K131379EarlysenseEarlysense, Ltd. · 2013 · 3 generations on7descendants
- K133661Chair Sensing Unit for Earlysense SystemEarlysense, Ltd. · 2014 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K830295 | Medilog 9000 System | Oxford Medilog, Inc. | 1983 | — |
| −2 | K971813 | EMBLA | Ferguson Medical | 1998 | — |
| −1 | K070375 | Earlysense ES-16 System | Earlysense, Ltd. | 2007 | — |
| 0 (this device) | K082626 | PAM 3000 | Wireless 2000 RF & Uwb Technologies, Ltd. | 2009 | — |
| +1 | K092062 | Everon 1.0 | Earlysense, Ltd. | 2010 | — |
| +1 | K202464 | Vital Sign Monitoring Sensor (Model :XK300) | Xandar Kardian, Inc. | 2021 | — |
| +2 | K120465 | Earlysense (Everon) System | Earlysense, Ltd. | 2012 | — |
| +3 | K131379 | Earlysense | Earlysense, Ltd. | 2013 | — |
| +3 | K133661 | Chair Sensing Unit for Earlysense System | Earlysense, Ltd. | 2014 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 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 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? (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 |
|---|---|---|---|
| * | K070375 | Earlysense ES-16 SystemSummary page 1…l. Predicate Device The Wireless 2000 PAMTM 3000 is substantially equivalent to the EarlySense ES-16 System from EarlySense Ltd (K070375) and LG1Tm Intelligent Medical Vigilance System from Hoana Medical Inc (K052446) IV. Intended Use… | 2007 |
| * | K052446 | LG1 Intelligent Medical Vigilance SystemSummary page 1…ent to the EarlySense ES-16 System from EarlySense Ltd (K070375) and LG1Tm Intelligent Medical Vigilance System from Hoana Medical Inc (K052446) IV. Intended Use of the Device The PAMm3000 system is intended to measure heart rate and respira… | 2006 |
What descends from it? (21)
See all 213 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 26 years and passes through 4 companies; a new generation was cleared every 9.8 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K092062 (Earlysense, Ltd., 2010) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K070375.
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. 2009, 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 PAAvTm3000 system is intended to measure heart rate and respiration rate m adult patients, m a general care hospital environment including, nursing homes The system momtors presence or absence of a patient in bed (bed exit) The system also times the length of continuous patient motion or absence of patient motion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082626: PAM 3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082626
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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