Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OOX — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
264 daysmedian FDA review time
801 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200754 | Hemosure Accu-Reader A100 | W.H.P.M., Inc. | 2022-06-02 | 801 | 0 |
| K191147 | OC-Auto SENSOR io iFOB Test | Eiken Chemical Co., Ltd. | 2020-01-02 | 247 | 0 |
| K163225 | AFIAS iFOB with AFIAS-50 | Immunostics Inc., | 2017-08-08 | 264 | 0 |
| K132167 | I-CHROMA IFOB WITH I-CHROMA READER | Boditech Med, Inc. | 2014-05-02 | 294 | 0 |
| K092330 | OC-SENSOR DIANA IFOB TEST | Polymedco Cancer Diagnostics, LLC | 2010-01-08 | 157 | 0 |
| K041408 | POLYMEDCO OC AUTO MICRO 80 FOB TEST | Polymedco, Inc. | 2004-10-21 | 147 | 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