Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cilco, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
174 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861334 | CILCO DIAMOND KNIVES & DIAMOND KNIFE LINEAR GAUGE | Cilco, Inc. | 1986-05-02 | 23 | 0 |
| K854969 | CILCO SONOMETRICS A&B DIGITAL SYSTEM (DIGISCAN) | Cilco, Inc. | 1986-02-27 | 78 | 0 |
| K844249 | K-SOL | Cilco, Inc. | 1985-04-30 | 179 | 0 |
| K843319 | CILCO I/A SURGICAL PACK | Cilco, Inc. | 1985-02-14 | 174 | 0 |
| K843992 | CILCOR OPHTHALMIC INSTRUMENTS | Cilco, Inc. | 1984-11-21 | 41 | 0 |
| K843447 | CILCO DIAMOND KNIFE | Cilco, Inc. | 1984-10-05 | 30 | 0 |
| K841099 | OCTOPUS 500/500E | Cilco, Inc. | 1984-06-19 | 99 | 0 |
| K840475 | CYSTOTOME, 140-S | Cilco, Inc. | 1984-04-05 | 62 | 0 |
| K832405 | OPTHALMIC ENDOSCOPE | Cilco, Inc. | 1983-11-21 | 123 | 0 |
| K827371 | CILCO ASCAN | Cilco, Inc. | 1982-07-09 | 102 | 0 |
| K821381 | IOL FORCEPS | Cilco, Inc. | 1982-06-14 | 35 | 0 |
| K820933 | CILCO I/A HANDPIECE | Cilco, Inc. | 1982-06-14 | 73 | 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