Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ruggles Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
205 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903485 | TITANIUM MESH | Ruggles Corp. | 1991-02-21 | 205 | 0 |
| K902818 | MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENT | Ruggles Corp. | 1990-09-20 | 85 | 1 |
| K902819 | LAMINECTOMY ROGEUR | Ruggles Corp. | 1990-08-09 | 43 | 0 |
| K902850 | ZEPPELIN INSTRUMENTS | Ruggles Corp. | 1990-07-18 | 19 | 0 |
| K893415 | TRANS-ORAL DEPTH GAUGE | Ruggles Corp. | 1989-06-07 | 36 | 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