Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Surgical Instruments Corp. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
187 daysmedian FDA review time
578 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K921716 | DISPOSABLE UNIPOLAR COAGULATOR PROBE SYSTEM | American Surgical Instruments Corp. | 1993-11-08 | 578 | 0 |
| K921457 | IRRIGATION PUMPS AND TUBING AND SUCTION TUBING | American Surgical Instruments Corp. | 1993-05-13 | 413 | 0 |
| K913944 | NEZHAT/DORSEY HYDRO DISSECTION PUMP & ACCESSORIES | American Surgical Instruments Corp. | 1992-03-09 | 187 | 0 |
| K913999 | NEZHAT DORSEY SUCTION PROBE W/INNER IRRIGA TUBE | American Surgical Instruments Corp. | 1991-11-01 | 56 | 0 |
| K911274 | UNIPOLAR COAGULATOR PROBE SYSTEM | American Surgical Instruments Corp. | 1991-06-20 | 90 | 0 |
| K896118 | NEZHAT/DORSEY HYDRO DISSECTION PUMP OB-GYN USE | American Surgical Instruments Corp. | 1990-03-28 | 156 | 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