Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Skypro Medical Supplies Company · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230707 | Skypro, Surgical Gown 6021 | Skypro Medical Supplies Company | 2023-10-12 | 212 | 0 |
| K202255 | Skypro, SP02 Mask (3) | Skypro Medical Supplies Company | 2021-12-24 | 501 | 0 |
| K152197 | Skypro, SP01 Mask | Skypro Medical Supplies Company | 2016-08-26 | 387 | 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