Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgidyne, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
129 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K892334 | LEONARD TUBE | Surgidyne, Inc. | 1989-05-31 | 56 | 0 |
| K883582 | VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM | Surgidyne, Inc. | 1988-10-03 | 42 | 0 |
| K864822 | VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS | Surgidyne, Inc. | 1987-01-15 | 37 | 0 |
| K860030 | SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID | Surgidyne, Inc. | 1986-02-12 | 37 | 0 |
| K852180 | SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC. | Surgidyne, Inc. | 1985-07-01 | 42 | 0 |
| K850634 | SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS | Surgidyne, Inc. | 1985-06-28 | 129 | 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