510(k) · Cleared
ClearedProteus Patch, Ingestible Sensor (Accessory)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Proteus Digital Health, Inc. · OZW Ingestible Event Marker
Cleared on May 7, 2013 as substantially equivalent to DEN120011 (Proteus Biomedical, Inc., 2012) and 1 other predicate after a 26-day review. Its family tree reaches back 5 generations to 1997. 6 later devices descend from it.
- Decided
- May 7, 2013
- Review
- 26 days
- Class
- Class II
- Product code
- OZW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K963725 (1997). 15 ancestors in all, the oldest K854030 (1986). 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 4 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 3 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 2 generations backK083174 HealthepodCard Guard Scientific Survival, Ltd. · 2009
- 1 generation backK093976 Raisin Personal MonitorProteus Biomedical, Inc. · 2010
- This deviceK131009 Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2013
- Descendant · cites it directly · 4 of its ownK133263 Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK150494 Proteus Digital Health Feedback DeviceProteus Digital Health, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK223463 Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK251088 Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK183052 ID-Cap SystemEtectrx, Inc. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K133263Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2014 · cites it directly4descendants
- K150494Proteus Digital Health Feedback DeviceProteus Digital Health, Inc. · 2015 · 2 generations on3descendants
- K223463Otsuka Digital Feedback Device-RWOtsuka America Pharmaceutical, Inc. · 2023 · 2 generations on1descendant
- K251088Otsuka Digital Feedback DeviceOtsuka America Pharmaceutical, Inc. · 2025 · 3 generations on0descendants
- K183052ID-Cap SystemEtectrx, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −4 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −3 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −2 | K083174 | Healthepod | Card Guard Scientific Survival, Ltd. | 2009 | — |
| −1 | K093976 | Raisin Personal Monitor | Proteus Biomedical, Inc. | 2010 | — |
| 0 (this device) | K131009 | Proteus Patch, Ingestible Sensor (Accessory) | Proteus Digital Health, Inc. | 2013 | — |
| +1 | K133263 | Proteus Patch, Proteus Ingestible Sensor (Accessory) | Proteus Digital Health, Inc. | 2014 | — |
| +2 | K150494 | Proteus Digital Health Feedback Device | Proteus Digital Health, Inc. | 2015 | — |
| +2 | K223463 | Otsuka Digital Feedback Device-RW | Otsuka America Pharmaceutical, Inc. | 2023 | — |
| +3 | K251088 | Otsuka Digital Feedback Device | Otsuka America Pharmaceutical, Inc. | 2025 | — |
| +3 | K183052 | ID-Cap System | Etectrx, Inc. | 2019 | — |
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 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 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 OZW? 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 OZW device
- #1 K251088 Otsuka Digital Feedback Devicescore 12.0 · 9 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | DEN120011 | Proteus Ingestion Confinmation Systems Our reading of the summary gave K113070, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN120011, Proteus Ingestion Confinmation Systems (Proteus Biomedical, Inc.), granted Jul 10, 2012; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2012 |
| * | K093976 | Raisin Personal MonitorSummary page 1…arker (21 CFR 880.6305, Product Code OZXD Unmodified Devices * Proteus Personal Monitor (K113070) * RaisinTM Personal Monitor (1(,093976) General Device Description Like the Proteus Personal Monitor (1(1 13070), the Proteus Patch is a body-worn sensor that collect… | 2010 |
What descends from it? (6)
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 16 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K133263 (Proteus Digital Health, Inc., 2014) has gone furthest, with 4 descendants of its own.
How does its category compare?
All OZW devicesOZW Ingestible Event Marker: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · OZW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OZW
Too few OZW 510(k)s in any year since 2007 to give a median.
Recalls per year · OZW
No recall names OZW since 2007.
Adverse event reports per year · OZW
2in 2018
MAUDE reports naming product code OZW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Proteus® Patch, also called the Patch, is a miniaturized, wearable data-logger for ambulatory recording of physiological and behavioral metrics such as heart rate, activity, body angle relative to gravity, and time-stamped, patient-logged events, including events signaled by swallowing the Ingestible Sensor accessory. The Proteus Patch enables unattended data collection for clinical and research applications. The Proteus Patch may be used in any instance where quantifiable analysis of event-associated physiological and behavioral heart rate, activity, and body position is desirable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131009: Proteus Patch, Ingestible Sensor (Accessory).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131009
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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