Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Otto Bock Orthopedic Industry, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
62 daysmedian FDA review time
231 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000739 | EVANTGARDE/ENDEAVOR POWERED WHEELCHAIR | Otto Bock Orthopedic Industry, Inc. | 2000-10-24 | 231 | 0 |
| K000678 | RAEBBITT/EVOLUTION POWERED WHEELCHAIR | Otto Bock Orthopedic Industry, Inc. | 2000-09-18 | 202 | 0 |
| K000497 | VOYAGER/VIPER WHEELCHAIR | Otto Bock Orthopedic Industry, Inc. | 2000-03-08 | 22 | 0 |
| K000602 | PROTEGE WHEELCHAIR | Otto Bock Orthopedic Industry, Inc. | 2000-03-03 | 9 | 0 |
| K991590 | C-LEG (3C100) | Otto Bock Orthopedic Industry, Inc. | 1999-07-08 | 62 | 1 |
| K951847 | AVANTGARDE | Otto Bock Orthopedic Industry, Inc. | 1995-05-12 | 22 | 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