Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eare Consulting Service — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K970180 | VSA 3000 VIBRATORYN SENSORY ANALYZER | Eare Consulting Service | 1997-04-25 | 98 | 0 |
| K950592 | ACCESSORIES FOE ORTHOPEDIC SURGICAL PROCEDURES | Eare Consulting Service | 1995-06-01 | 112 | 0 |
| K944428 | LITE-BLADE | Eare Consulting Service | 1994-11-15 | 64 | 0 |
| K934981 | DENTAL DRILL | Eare Consulting Service | 1994-02-03 | 107 | 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