Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medical Hospital Equipment · 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) |
|---|---|---|---|---|---|
| K852616 | MIRAGE INTRAVENOUS INFUSION SET OLOVSON-STERILE | Medical Hospital Equipment | 1986-04-07 | 299 | 0 |
| K852615 | R.R. AGHI HYPODERMIC SINGLE LUMEN NEEDLE | Medical Hospital Equipment | 1986-03-21 | 282 | 0 |
| K852503 | R.R. PRONTO SIRINGA | Medical Hospital Equipment | 1985-11-13 | 154 | 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