Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Otto Bock Healthcare Products GmbH · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253256 | myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. ( | Otto Bock Healthcare Products GmbH | 2026-04-22 | 205 | 0 |
| K191179 | Myo Plus | Otto Bock Healthcare Products GmbH | 2019-09-04 | 125 | 0 |
| K141812 | MYGAIT STIMULATION SYSTEM | Otto Bock Healthcare Products GmbH | 2015-04-02 | 269 | 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