Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HXR — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K983882 | MICRO ENDOSCOPE-STAINLESS STEEL, MODEL MMD-1300, MICRO ENDOS | Micro-Medical Devices, Inc. | 1999-03-15 | 133 | 0 |
| K873387 | VIDEO ARTHROSCOPE, 1.7MM X 55 MM | Arthropedics, Inc. | 1987-11-25 | 152 | 0 |
| K872281 | RAYLOR FUSION FUNNEL | Cedar Surgical, Inc. | 1987-11-02 | 139 | 0 |
| K853436 | H-H HUNTER PASSIVE TENDON IMPLANT | Holter-Hausner Intl. | 1985-10-16 | 62 | 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