Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Hydro-Surgical Instruments, Inc. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
169 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953574 | NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAG SQUEEZER | American Hydro-Surgical Instruments, Inc. | 1995-09-29 | 60 | 0 |
| K953481 | NEZHAT-DORSEY HYDRO-DISSECTION UNIVERSAL BAGSQUEEZER | American Hydro-Surgical Instruments, Inc. | 1995-08-16 | 23 | 0 |
| K952070 | NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENC | American Hydro-Surgical Instruments, Inc. | 1995-07-26 | 85 | 0 |
| K946380 | NEZHAT-DORSEY REUSABLE ASPIRATION-VAC PROBES WITH AND WITHOU | American Hydro-Surgical Instruments, Inc. | 1995-07-06 | 205 | 0 |
| K951300 | NEZHAT-DORSEY THERMAL RETENTION SYSTEM | American Hydro-Surgical Instruments, Inc. | 1995-06-20 | 90 | 0 |
| K950499 | NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS | American Hydro-Surgical Instruments, Inc. | 1995-06-16 | 130 | 0 |
| K951119 | NEZHAT-DORSEY SPECIMEN CONTAINER SYSTEM | American Hydro-Surgical Instruments, Inc. | 1995-06-13 | 95 | 0 |
| K952421 | NEZHAT-DORSEY REUSABLE UNIPOLAR COAGULATOR PROBE INSERTS | American Hydro-Surgical Instruments, Inc. | 1995-06-08 | 16 | 0 |
| K951733 | NEXHAT-DORSEY PENCIL-GRIP TRUMPET VALVE WITH CUTTING AND COA | American Hydro-Surgical Instruments, Inc. | 1995-05-31 | 47 | 0 |
| K951732 | NEZHAT-DORESEY PENCIL-GRIP HANDLES | American Hydro-Surgical Instruments, Inc. | 1995-05-24 | 40 | 0 |
| K951731 | NEZHAT-DORESY ELECTROSURGICAL HAND CONTROL ATTACHMENTS | American Hydro-Surgical Instruments, Inc. | 1995-05-16 | 32 | 0 |
| K951086 | NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM AND ACCESSORIES | American Hydro-Surgical Instruments, Inc. | 1995-03-16 | 7 | 0 |
| K950507 | NEZHAT-DORSEY LAPAROSCOPIC HAND INSTRUMENTS | American Hydro-Surgical Instruments, Inc. | 1995-03-06 | 28 | 0 |
| K946089 | NEZHAT-DORSEY(TM) REUSABLE ASPIRATION-VAC(TM) PROBES WITH AN | American Hydro-Surgical Instruments, Inc. | 1995-03-06 | 83 | 0 |
| K945694 | NEZHAT-DORSEY BIPOLAR ELECTROSURGICAL FORCEPS, SURFACE ELECT | American Hydro-Surgical Instruments, Inc. | 1995-02-17 | 88 | 0 |
| K945317 | NEZHAT-DORSEY (TM) ELECTROSHIELD(TM) PROBES AND ACCESSORIES | American Hydro-Surgical Instruments, Inc. | 1995-02-01 | 92 | 0 |
| K943927 | END-O-FOG ENDOSCOPIC FOG ELIMINATION SYSTEM | American Hydro-Surgical Instruments, Inc. | 1994-09-16 | 35 | 0 |
| K930572 | NEZHAT-DORSEY HYDRO-DISSECTION SYSTEM II PUMP | American Hydro-Surgical Instruments, Inc. | 1993-07-23 | 169 | 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