Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Accelerated Innovation, LLC — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
96 daysmedian FDA review time
179 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081127 | ACCIN TOTAL KNEE SYSTEM | Accelerated Innovation, LLC | 2008-10-17 | 179 | 0 |
| K080647 | ACCIN BIPOLAR HEAD SYSTEM | Accelerated Innovation, LLC | 2008-07-08 | 123 | 0 |
| K080539 | ACCIN UNIPOLAR HEAD SYSTEM | Accelerated Innovation, LLC | 2008-06-02 | 96 | 0 |
| K073120 | ACCIN PATELLOFEMORAL SYSTEM | Accelerated Innovation, LLC | 2008-02-29 | 116 | 0 |
| K073531 | ACCIN PEDICLE SCREW SYSTEM | Accelerated Innovation, LLC | 2008-02-04 | 49 | 0 |
| K073530 | ACCIN ANTERIOR CERVICAL PLATE SYSTEM | Accelerated Innovation, LLC | 2008-01-31 | 45 | 0 |
| K073068 | ACCIN HIP SYSTEM | Accelerated Innovation, LLC | 2008-01-10 | 72 | 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