Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Accurate Surgical Instruments Co. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
171 daysmedian FDA review time
344 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950042 | SWAN NECK PRESTERNAL PERITONEAL DIALYSIS CATHETER | Accurate Surgical Instruments Co. | 1995-12-15 | 344 | 0 |
| K920515 | INSERTION | Accurate Surgical Instruments Co. | 1992-05-04 | 90 | 0 |
| K910786 | TROCAR (FALLER STYLET) | Accurate Surgical Instruments Co. | 1991-09-19 | 206 | 0 |
| K910785 | TITANIUM CATHETER EXTENDER | Accurate Surgical Instruments Co. | 1991-08-22 | 178 | 0 |
| K910787 | TITANIUM CONNECTOR (2 PART) | Accurate Surgical Instruments Co. | 1991-08-15 | 171 | 0 |
| K862046 | SWAN-NECK PERITONEAL DIALYSIS CATHETERS | Accurate Surgical Instruments Co. | 1986-06-19 | 21 | 0 |
| K850214 | STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN | Accurate Surgical Instruments Co. | 1985-07-26 | 185 | 0 |
| K813487 | CATHETER BUBBLE STAND | Accurate Surgical Instruments Co. | 1981-12-31 | 30 | 0 |
| K813488 | CATHETER REGULAR | Accurate Surgical Instruments Co. | 1981-12-31 | 30 | 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