Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LLF · 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) |
|---|---|---|---|---|---|
| K870773 | ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER | Hgm, Inc. | 1987-07-10 | 134 | 0 |
| K864610 | CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE | Inframed, Inc. | 1987-06-18 | 210 | 0 |
| K860977 | MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION | Britt Corp., Inc. | 1986-10-16 | 216 | 0 |
| K833497 | COOPER MEDICAL MODEL 770 | Cooper Medical Corp. | 1984-04-17 | 189 | 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