Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MY01, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
168 daysmedian FDA review time
241 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251900 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2026-01-16 | 210 | 0 |
| K242997 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2025-03-13 | 168 | 0 |
| K220952 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2022-05-24 | 53 | 0 |
| K210525 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2021-04-22 | 58 | 0 |
| K202635 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020-12-10 | 90 | 0 |
| K193321 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020-07-30 | 241 | 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