Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bio-Medical Devices, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
139 daysmedian FDA review time
247 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040485 | MAXAIR SURGICAL HELMET SYSTEM | Bio-Medical Devices, Inc. | 2004-10-18 | 236 | 1 |
| K981888 | SMOKE-EVAC | Bio-Medical Devices, Inc. | 1998-10-15 | 139 | 0 |
| K955149 | MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL | Bio-Medical Devices, Inc. | 1996-01-24 | 72 | 0 |
| K955151 | MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR | Bio-Medical Devices, Inc. | 1996-01-24 | 72 | 0 |
| K955150 | MAXI-FLOW | Bio-Medical Devices, Inc. | 1996-01-23 | 71 | 0 |
| K940156 | THE REEL THING | Bio-Medical Devices, Inc. | 1994-06-07 | 146 | 0 |
| K933742 | TOP GUN | Bio-Medical Devices, Inc. | 1994-04-07 | 247 | 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