Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Acist Medical Systems — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
426 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132474 | CARDIOVASCULAR PRESSURE MEASUREMENT (CPM) SYSTEM, NAVVUS CAT | Acist Medical Systems | 2014-01-30 | 176 | 0 |
| K020892 | ACIST GENTOO CONTRAST INJECTION SYSTEM | Acist Medical Systems | 2003-01-27 | 314 | 0 |
| K021015 | ACIST PLUS 4 ANGIOGRAPHIC CATHETER | Acist Medical Systems | 2002-04-26 | 28 | 0 |
| K991103 | MODIFICATION TO ACIST CL 100H | Acist Medical Systems | 2000-05-31 | 426 | 3 |
| K000013 | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000 | Acist Medical Systems | 2000-03-28 | 85 | 0 |
| K993774 | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH | Acist Medical Systems | 1999-12-07 | 29 | 0 |
| K984058 | ACIST INJECTOR SYSTEM, MODEL CL100 H | Acist Medical Systems | 1999-02-11 | 90 | 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