Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Access Surgical Intl., Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
61 daysmedian FDA review time
188 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K954536 | BLADE, SCALPEL & BLADE, HANDEL | Access Surgical Intl., Inc. | 1995-11-29 | 61 | 0 |
| K953376 | ACCESS POINT | Access Surgical Intl., Inc. | 1995-09-12 | 56 | 0 |
| K945545 | ACCESS SURGICAL INT'L THORACIC ENDOSCOPIC SURGICAL INSTRUMEN | Access Surgical Intl., Inc. | 1995-01-12 | 59 | 0 |
| K944974 | ACCESS POINT | Access Surgical Intl., Inc. | 1994-11-08 | 28 | 0 |
| K940587 | FLEX-I-PORT | Access Surgical Intl., Inc. | 1994-03-29 | 49 | 0 |
| K933192 | ACCESS SURGICAL INT'L INC. ENDOSCOPIC SURG. INST. | Access Surgical Intl., Inc. | 1993-11-18 | 141 | 0 |
| K922424 | ACCESS SURGICAL INT'L ENDOSCOPIC SURGICAL INSTRUM. | Access Surgical Intl., Inc. | 1992-11-25 | 188 | 0 |
| K922423 | ACCESS SURGICAL BIPOLAR ENDOSCOPIC SURG. INSTRUM. | Access Surgical Intl., Inc. | 1992-11-18 | 181 | 0 |
| K922425 | ACCESS SURGICAL MONOPOLAR ENDOSCOPIC SURG. INSTRUM | Access Surgical Intl., Inc. | 1992-11-17 | 180 | 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