510(k) · Cleared
ClearedRaisin Personal Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Proteus Biomedical, Inc. · DXH Transmitters And Receivers, Electrocardiograph, Telephone
Cleared on Mar 25, 2010 as substantially equivalent to K083174 (Card Guard Scientific Survival, Ltd., 2009) and 2 other predicates after a 91-day review. Its family tree reaches back 4 generations to 1997. 12 later devices descend from it.
- Decided
- Mar 25, 2010
- Review
- 91 days
- Class
- Class II
- Product code
- DXH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K963725 (1997). 13 ancestors in all, the oldest K854030 (1986). 12 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 3 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 2 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 1 generation backK083174 HealthepodCard Guard Scientific Survival, Ltd. · 2009
- This deviceK093976 Raisin Personal MonitorProteus Biomedical, Inc. · 2010
- Descendant · cites it directly · 6 of its ownK131009 Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2013
- Descendant · 2 generations on · 4 of its ownK133263 Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK110015 Vitalsens, Aingeal, V-PodIntelesens Limited · 2011
- Descendant · 3 generations on · 3 of its ownK150494 Proteus Digital Health Feedback DeviceProteus Digital Health, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK223463 Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc. · 2023
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K131009Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2013 · cites it directly6descendants
- K133263Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2014 · 2 generations on4descendants
- K110015Vitalsens, Aingeal, V-PodIntelesens Limited · 2011 · cites it directly4descendants
- K150494Proteus Digital Health Feedback DeviceProteus Digital Health, Inc. · 2015 · 3 generations on3descendants
- K223463Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −3 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −2 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −1 | K083174 | Healthepod | Card Guard Scientific Survival, Ltd. | 2009 | — |
| 0 (this device) | K093976 | Raisin Personal Monitor | Proteus Biomedical, Inc. | 2010 | — |
| +1 | K131009 | Proteus Patch, Ingestible Sensor (Accessory) | Proteus Digital Health, Inc. | 2013 | — |
| +2 | K133263 | Proteus Patch, Proteus Ingestible Sensor (Accessory) | Proteus Digital Health, Inc. | 2014 | — |
| +1 | K110015 | Vitalsens, Aingeal, V-Pod | Intelesens Limited | 2011 | — |
| +3 | K150494 | Proteus Digital Health Feedback Device | Proteus Digital Health, Inc. | 2015 | — |
| +3 | K223463 | Otsuka Digital Feedback Device-RW | Otsuka America Pharmaceutical, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 DXH? 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 DXH device
- #1 K243438 MEMO Patch M (MPT-E08R-UNC01)score 12.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K083174 | HealthepodSummary page 1…Logging Device Classification name: Cardiovascular Transmitter and Receiver (Product Code DXH) 1A.45 -- Predicate Devices HealthePodTm (1(083174) Actiheart® (K052489) Actiwatch-Scoreg (1K991033) 1.4.6 -- Device Description and Technologic Charact… | 2009 |
| * | K052489 | ActiheartSummary page 1…sification name: Cardiovascular Transmitter and Receiver (Product Code DXH) 1A.45 -- Predicate Devices HealthePodTm (1(083174) Actiheart® (K052489) Actiwatch-Scoreg (1K991033) 1.4.6 -- Device Description and Technologic Characteristics The RaisinTm Personal Mo… | 2005 |
| * | K991033 | Actiwatch-ScoreSummary page 1…er and Receiver (Product Code DXH) 1A.45 -- Predicate Devices HealthePodTm (1(083174) Actiheart® (K052489) Actiwatch-Scoreg (1K991033) 1.4.6 -- Device Description and Technologic Characteristics The RaisinTm Personal Monitor (RPM) is a miniaturized, ambulatory… | 1999 |
What descends from it? (12)
See all 122 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 13 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K131009 (Proteus Digital Health, Inc., 2013) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K083174.
How does its category compare?
All DXH devicesDXH Transmitters And Receivers, Electrocardiograph, Telephone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DXH
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXH
322in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXH
27in 2025
MAUDE reports naming product code DXH, 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 | 3 | 202 | 0 | 0 |
| 2008 | 7 | 41 | 4 | 0 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 3 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 3 | 206 | 0 | 1 |
| 2014 | 6 | 186 | 0 | 1 |
| 2015 | 4 | 142 | 1 | 0 |
| 2016 | 1 | — | 0 | 5 |
| 2017 | 5 | 150 | 0 | 4 |
| 2018 | 4 | 294 | 0 | 0 |
| 2019 | 6 | 177 | 0 | 0 |
| 2020 | 5 | 141 | 0 | 5 |
| 2021 | 3 | 107 | 0 | 2 |
| 2022 | 4 | 150 | 0 | 6 |
| 2023 | 1 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 4 | 322 | 0 | 27 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Raisin TM Personal Monitor is a miniaturized, wearable data-logger for ambulatory recording of heart rate, activity, body angle relatively to gravity, and time-stamped, patient-logged events. The Raisin TM PersonalMonitor enables unattended data collection for clinical and research applications. The RaisinTM PersonalMonitor may be used in any instance where quantifiable analysis of event-associated heart rate, activity, and body position is desirable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093976 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093976: Raisin Personal Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093976
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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