Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HBN · 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) |
|---|---|---|---|---|---|
| K900472 | SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI | Skytron, Div. the Kmw Group, Inc. | 1990-09-04 | 216 | 0 |
| K822426 | MCINTYRE MICROSCOPE STAND | Surgi-Quip Inc.U | 1982-09-02 | 21 | 0 |
| K822428 | SURGI-QUIP MICROSCOPE STAND | Surgi-Quip Inc.U | 1982-09-02 | 21 | 0 |
| K822012 | BINOCULAR OPERATING MICROSCOPES & | Kelleher Corp. | 1982-07-30 | 22 | 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