Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Surgical Co., Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
847 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K834162 | VIT PAC | American Surgical Co., Inc. | 1986-02-07 | 847 | 0 |
| K834160 | VITREONIC PLUS | American Surgical Co., Inc. | 1986-02-07 | 847 | 0 |
| K841738 | AMER. SURGICAL CORP. EXTRA PLUS PAK | American Surgical Co., Inc. | 1984-10-05 | 161 | 0 |
| K833617 | EXTRA PLUS TM | American Surgical Co., Inc. | 1983-12-28 | 75 | 0 |
| K834161 | UNIVERSAL PAC | American Surgical Co., Inc. | 1983-12-28 | 75 | 0 |
| K833697 | EXTRA SENSORY PAK-DISPOS. ACCESS | American Surgical Co., Inc. | 1983-12-28 | 71 | 0 |
| K834158 | EXTRA SENSORY PLUS | American Surgical Co., Inc. | 1983-12-28 | 75 | 0 |
| K834163 | ULTRAVIT | American Surgical Co., Inc. | 1983-12-28 | 75 | 0 |
| K834159 | PHACOTRON PLUS | American Surgical Co., Inc. | 1983-12-28 | 75 | 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