Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spinalight, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
172 daysmedian FDA review time
349 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172536 | Atlas Percussion Adjusting Instrument | Spinalight, Inc. | 2018-06-20 | 302 | 0 |
| K001476 | TORQUE INSTRUMENT, MODEL 8500 | Spinalight, Inc. | 2000-08-04 | 85 | 0 |
| K955540 | HAND HELD ATLAS INSTRUMENT | Spinalight, Inc. | 1996-03-04 | 90 | 0 |
| K946258 | MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT | Spinalight, Inc. | 1995-11-20 | 349 | 1 |
| K945954 | MODELS 4100 AND 4300 MULTITHERAPY | Spinalight, Inc. | 1995-01-19 | 44 | 0 |
| K933621 | HILO TABLE | Spinalight, Inc. | 1994-01-07 | 172 | 0 |
| K933622 | FLEXION DISTRACTION TABLE | Spinalight, Inc. | 1994-01-07 | 172 | 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