Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HNY — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
45 daysmedian FDA review time
133 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K961524 | STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND | Sterilab, Inc. | 1996-05-16 | 24 | 0 |
| K880345 | CYSTOTOMES/KNIFES | Myocure, Inc. | 1988-05-03 | 98 | 0 |
| K874976 | PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 | 133 | 0 |
| K874993 | PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 | 133 | 0 |
| K875001 | PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 | 131 | 0 |
| K874983 | PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 | 133 | 0 |
| K874997 | PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 | 133 | 0 |
| K874975 | PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME | Advanced Surgical Products, Inc. | 1988-04-13 | 133 | 0 |
| K873163 | VAN DELLEN IRRIGATING CYSTOTOME | Van Dellen, Ltd. | 1987-09-04 | 24 | 0 |
| K871365 | CAPSULECTOMER CYSTOTOME | Noetix, Inc. | 1987-04-16 | 9 | 0 |
| K870439 | LOOK IRRIGATING CYSTOTOMES | Look, Inc. | 1987-02-20 | 17 | 0 |
| K862709 | MECHANICAL CYSTITOME | Rudolph Beaver, Inc. | 1986-08-01 | 16 | 0 |
| K852934 | PRECISION - COSMET CAPSULE COUPEUR | Precision-Cosmet Co., Inc. | 1985-08-08 | 30 | 0 |
| K841101 | CLAYMAN-PAREL CAPSULE COUPEUR | Miami Eye Technology, Inc. | 1984-05-16 | 64 | 0 |
| K840475 | CYSTOTOME, 140-S | Cilco, Inc. | 1984-04-05 | 62 | 0 |
| K840660 | POSTERIOR CAPSULOTOMY CYSTITOME | Sharpoint, Inc. | 1984-03-16 | 30 | 0 |
| K840659 | ANTERIOR CAPSULECTOMY CYSTITOME | Sharpoint, Inc. | 1984-03-16 | 30 | 0 |
| K831916 | DISPOSABLE CYSTOTOME | CooperVision, Inc. | 1983-07-12 | 28 | 0 |
| K830040 | DISPOSABLE CYSTOTOME | Contemporary Surgical Systems, Inc. | 1983-02-07 | 31 | 0 |
| K790244 | CYSTOTOMES | Visitec Co. | 1979-02-12 | 45 | 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