Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PPW — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
219 daysmedian FDA review time
266 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K254066 | Etiometry Platform | Etiometry, Inc. | 2026-04-03 | 106 | 0 |
| K252204 | prolaio eVO2peak Module (Version 1.0) | Prolaio, Inc. | 2025-12-16 | 155 | 0 |
| K241479 | Etiometry Platform (DAV 5.4 RAE 9.2) | Etiometry, Inc. | 2025-02-12 | 264 | 0 |
| K223578 | T3 Platform software | Etiometry, Inc. | 2023-07-07 | 219 | 0 |
| K213230 | T3 Platform Software | Etiometry, Inc. | 2022-06-22 | 266 | 0 |
| K213255 | CipherOx CRI Tablet | Flashback Technologies, Inc. | 2022-06-17 | 260 | 0 |
| K173929 | CipherOx CRI M1 | Flashback Technologies, Inc. | 2018-07-24 | 210 | 0 |
| DEN160020 | CipherOx CRI Tablet | Flashback Technologies, Inc. | 2016-12-21 | 211 | 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