Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Orthofab, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
36 daysmedian FDA review time
330 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962565 | POWERED WHEELCHAIR | Orthofab, Inc. | 1997-03-20 | 262 | 0 |
| K952675 | ORTHOFAB WHEELCHAIR | Orthofab, Inc. | 1996-05-07 | 330 | 0 |
| K950904 | ORTHOFAB WHEELCHAIR ASTRA (FOLDING MANUAL WHEELCHAIR) | Orthofab, Inc. | 1995-04-05 | 36 | 0 |
| K950903 | ORTHOFAB WHEELCHAIR ULTIMA (RIGID FRAME MANUAL WHEELCHAIR) | Orthofab, Inc. | 1995-04-05 | 36 | 0 |
| K884812 | KARMA-RS, KARMA-FS WHEELCHAIRS | Orthofab, Inc. | 1988-12-27 | 40 | 0 |
| K860095 | DIGIKIT NONPNEUMATIC TOURNIQUET | Orthofab, Inc. | 1986-01-24 | 14 | 0 |
| K852661 | APOLLO STERILE BLADES | Orthofab, Inc. | 1985-07-11 | 17 | 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