Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ACIST Medical Systems, Inc. — Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
77 daysmedian FDA review time
264 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery System | ACIST Medical Systems, Inc. | 2026-08-03 | 41 | 0 |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mo | Acist Medical Systems, Inc. | 2026-05-13 | 264 | 0 |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Lo | Acist Medical Systems, Inc. | 2026-05-13 | 266 | 0 |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | Acist Medical Systems, Inc. | 2024-07-17 | 219 | 0 |
| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Deli | Acist Medical Systems, Inc. | 2020-12-17 | 77 | 0 |
| K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Cath | Acist Medical Systems, Inc. | 2020-03-20 | 123 | 1 |
| K190473 | ACIST RXi System and Navvus II Catheter | Acist Medical Systems, Inc. | 2019-09-13 | 198 | 0 |
| K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A100 | Acist Medical Systems, Inc. | 2019-07-18 | 87 | 0 |
| K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi Sy | Acist Medical Systems, Inc. | 2019-06-27 | 57 | 0 |
| K171646 | ACISTCVi® Contrast Delivery System | Acist Medical Systems, Inc. | 2018-02-16 | 256 | 0 |
| K173063 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi Sy | Acist Medical Systems, Inc. | 2017-10-23 | 24 | 0 |
| K172216 | ACIST RXi Mini System | Acist Medical Systems, Inc. | 2017-08-18 | 25 | 0 |
| K093657 | ADAGIO RETRACTING ECG LEAD WIRES | Acist Medical Systems, Inc. | 2010-01-15 | 51 | 0 |
| K052744 | C2000 AUTOMATED MANIFOLD KIT | Acist Medical Systems, Inc. | 2005-12-16 | 77 | 1 |
| K040298 | ACIST ANTIOGRAPHIC INJECTION SYSTEM CONTRAST MANAGEMENT DISP | Acist Medical Systems, Inc. | 2004-03-15 | 35 | 3 |
| K012983 | ACIST 4 FRENCH ANGIOGRAPHIC CATHETER | Acist Medical Systems, Inc. | 2002-03-13 | 189 | 0 |
| K010390 | ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS | Acist Medical Systems, Inc. | 2001-03-09 | 28 | 1 |
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