Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biosurge, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
102 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884620 | ASD SINGLE LUMEN NEEDLE | Biosurge, Inc. | 1988-11-21 | 17 | 0 |
| K875016 | BIOSURGE MODEL ILVC-1 | Biosurge, Inc. | 1988-02-29 | 87 | 0 |
| K874602 | ASD-BIO ANTI-STICK DEVICE | Biosurge, Inc. | 1988-02-19 | 102 | 0 |
| K875023 | BIOSURGE MODEL OASYS-II | Biosurge, Inc. | 1988-02-12 | 70 | 0 |
| K871258 | BIOSURGE MODEL OASYS | Biosurge, Inc. | 1987-05-21 | 51 | 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