Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgeon Surgical Instrumentation, Inc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
81 daysmedian FDA review time
165 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954241 | SURGIN GENISIS PHACOEMULSIFIER | Surgeon Surgical Instrumentation, Inc. | 1995-12-01 | 81 | 0 |
| K932281 | VERRES NEEDLE | Surgeon Surgical Instrumentation, Inc. | 1993-08-06 | 86 | 0 |
| K922038 | CO2 INSUFFLATION TUBING | Surgeon Surgical Instrumentation, Inc. | 1992-10-13 | 165 | 0 |
| K904010 | SURGICAL ASPIRATOR KIT | Surgeon Surgical Instrumentation, Inc. | 1990-11-21 | 84 | 0 |
| K890447 | HEMORRHAGE OCCLUDOR | Surgeon Surgical Instrumentation, Inc. | 1989-02-23 | 27 | 0 |
| K880543 | UNI-PORT | Surgeon Surgical Instrumentation, Inc. | 1988-07-01 | 143 | 0 |
| K881232 | SURGIN EYE SHIELD | Surgeon Surgical Instrumentation, Inc. | 1988-04-13 | 22 | 0 |
| K861203 | MULTI-SPIKE | Surgeon Surgical Instrumentation, Inc. | 1986-04-28 | 27 | 0 |
| K852229 | STERILE EYE PACKS OR TRAYS | Surgeon Surgical Instrumentation, Inc. | 1985-06-07 | 16 | 0 |
| K830859 | I/A KIT | Surgeon Surgical Instrumentation, Inc. | 1983-05-02 | 46 | 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