Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Blue Sky Medical Group Incorporated · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K061919 | VERSATILE 1 EZCARE WOUND VACUUM SYSTEM | Blue Sky Medical Group Incorporated | 2007-02-05 | 214 | 0 |
| K061367 | BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500 | Blue Sky Medical Group Incorporated | 2006-08-10 | 86 | 0 |
| K052456 | MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEM | Blue Sky Medical Group Incorporated | 2005-11-04 | 58 | 0 |
| K042134 | VERSATILE 1 WOUND VACUUM SYSTEM | Blue Sky Medical Group Incorporated | 2004-11-01 | 84 | 2 |
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