Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PYT · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
238 daysmedian FDA review time
444 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253694 | Natural Cycles | Natural Cycles Nordic AB | 2026-07-17 | 238 | 0 |
| K250561 | Natural Cycles | Natural Cycles Nordic AB | 2025-03-21 | 24 | 0 |
| K241006 | Natural Cycles | Natural Cycles Nordic AB | 2024-07-11 | 90 | 0 |
| K231274 | Natural Cycles | Natural Cycles Nordic AB | 2023-08-24 | 114 | 0 |
| K202897 | Natural Cycles | Natural Cycles Nordic AB | 2021-06-24 | 268 | 0 |
| K193330 | Clue Birth Control | Biowink GmbH | 2021-02-18 | 444 | 0 |
| DEN170052 | Natural Cycles | Natural Cycles Nordic AB | 2018-08-10 | 324 | 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