510(k) · Cleared
ClearedID-Cap System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Etectrx, Inc. · OZW Ingestible Event Marker
Cleared on Dec 6, 2019 as substantially equivalent to K150494 (Proteus Digital Health, Inc., 2015) after a 399-day review. Its family tree reaches back 8 generations to 1997.
- Decided
- Dec 6, 2019
- Review
- 399 days
- Class
- Class II
- Product code
- OZW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K963725 (1997). 18 ancestors in all, the oldest K854030 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK963725 Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device…Card Guard, Ltd. · 1997
- 7 generations backK012223 CG-2211 Selfcheck Ecg TransmitterCard Guard Scientific Survival, Ltd. · 2001
- 6 generations backK042254 PMP4 Selfcheck EcgCard Guard Scientific Survival, Ltd. · 2005
- 5 generations backK083174 HealthepodCard Guard Scientific Survival, Ltd. · 2009
- 4 generations backK093976 Raisin Personal MonitorProteus Biomedical, Inc. · 2010
- 3 generations backK131009 Proteus Patch, Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2013
- 2 generations backK133263 Proteus Patch, Proteus Ingestible Sensor (Accessory)Proteus Digital Health, Inc. · 2014
- 1 generation backK150494 Proteus Digital Health Feedback DeviceProteus Digital Health, Inc. · 2015
- This deviceK183052 ID-Cap SystemEtectrx, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963725 | Model CG-2206 Personal Electrocardiogram (Ecg) Transmitter Device (Modified) | Card Guard, Ltd. | 1997 | — |
| −7 | K012223 | CG-2211 Selfcheck Ecg Transmitter | Card Guard Scientific Survival, Ltd. | 2001 | — |
| −6 | K042254 | PMP4 Selfcheck Ecg | Card Guard Scientific Survival, Ltd. | 2005 | — |
| −5 | K083174 | Healthepod | Card Guard Scientific Survival, Ltd. | 2009 | — |
| −4 | K093976 | Raisin Personal Monitor | Proteus Biomedical, Inc. | 2010 | — |
| −3 | 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 | K150494 | Proteus Digital Health Feedback Device | Proteus Digital Health, Inc. | 2015 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K150494 | Proteus Digital Health Feedback DeviceSummary page 4…880.6305 OZW – Ingestible event marker Class II Predicate Devices: K150494 – Ingestion Event Marker (IEM) Data recorder (Patch) Device Description The ID-Cap Syste… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 18 ancestors has a recall of any class.
- 1 other device also cites its predicate K150494.
How does its category compare?
All OZW devicesOZW Ingestible Event Marker: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 ID-Cap System consists of a wearable reader for ambulatory recording of events signaled by swallowing the ID-Capsule which contains the ID-Tag, an ingestible sensor. The ID-Cap System is intended to log, track, and trend intake times and enables unattended data collection for clinical applications. The ID-Cap System may be used in any instance where quantifiable analysis of ingestion events, including events signaled by the co-incidence with or co-ingestion with the ID-Capsule, is desirable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183052 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183052: ID-Cap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183052
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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