Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OZW · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
107 daysmedian FDA review time
399 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251088 | Otsuka Digital Feedback Device | Otsuka America Pharmaceutical, Inc. | 2025-06-30 | 82 | 0 |
| K223463 | Otsuka Digital Feedback Device-RW | Otsuka America Pharmaceutical, Inc. | 2023-08-11 | 268 | 0 |
| K183052 | ID-Cap System | Etectrx, Inc. | 2019-12-06 | 399 | 0 |
| K150494 | Proteus Digital Health Feedback Device | Proteus Digital Health, Inc. | 2015-06-27 | 122 | 0 |
| K133263 | PROTEUS PATCH, PROTEUS INGESTIBLE SENSOR (ACCESSORY) | Proteus Digital Health, Inc. | 2014-02-07 | 107 | 0 |
| K131524 | PROTEUS PATCH INCLUDING INGESTIBLE SENSOR | Proteus Digital Health, Inc. | 2013-06-23 | 26 | 0 |
| K131009 | PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY) | Proteus Digital Health, Inc. | 2013-05-07 | 26 | 0 |
| DEN120011 | PROTEUS INGESTION CONFINMATION SYSTEMS | Proteus Biomedical, Inc. | 2012-07-10 | 60 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda