Acist Medical Systems, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Acist Medical Systems, Inc.” (first 1999, latest 2026), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 86 days. Since 2017 the median was 105 days, against 127 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 176 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 2 | 24 |
| 2018 | 1 | 256 |
| 2019 | 3 | 87 |
| 2020 | 2 | 100 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 219 |
| 2025 | 0 | — |
| 2026 | 3 | 264 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Acist Medical Systems, Inc. took a median 105 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 127 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | 12 | 12 |
| OBJ | Catheter, Ultrasound, Intravascular | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| DXO | Transducer, Pressure, Catheter Tip | 2 | 2 |
| IZQ | Injector, Contrast Medium, Automatic | 2 | 2 |
| DRQ | Amplifier And Signal Conditioner, Transducer Signal | 1 | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| OBI | Catheter, Pressure Monitoring, Cardiac | 1 | 1 |
Review panels
- General Hospital (14)
- Cardiovascular (10)
Most recent Acist Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K262115 | VueJect® Ultrasound Enhancing Agent Delivery System | IZQ | 2026-08-03 | 41 |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable | DXT | 2026-05-13 | 264 |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) | DXT | 2026-05-13 | 266 |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_ | DXO | 2024-07-17 | 219 |
| K203004 | ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System | DXT | 2020-12-17 | 77 |
| K193183 | ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter | OBJ | 2020-03-20 | 123 |
| K190473 | ACIST RXi System and Navvus II Catheter | OBI | 2019-09-13 | 198 |
| K191060 | ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit | DXT | 2019-07-18 | 87 |
| K191175 | ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System | OBJ | 2019-06-27 | 57 |
| K171646 | ACISTCVi® Contrast Delivery System | DXT | 2018-02-16 | 256 |
14 earlier clearances. See the full list in Caduvo.
Recalls
9 product recalls in 9 recall events; 0 initiated in the last five years. Most recent: 2021-01-22.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Acist Medical Systems, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02060682: Post-Market Registry of the ACIST CPM System and Navvus Catheter in Clinical Practice (Completed, started 2014-02)
Frequently asked questions
How many FDA 510(k) clearances are listed under Acist Medical Systems, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Acist Medical Systems, Inc.” (first 1999, latest 2026), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Acist Medical Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Acist Medical Systems, Inc. is 86 days. Since 2017: 105 days, versus 127 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Acist Medical Systems, Inc.?
The most frequent FDA product codes under this applicant name are DXT (Injector And Syringe, Angiographic, 12); OBJ (Catheter, Ultrasound, Intravascular, 3); DQO (Catheter, Intravascular, Diagnostic, 2).
Next steps
- See all 24 Acist Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXT, Acist Medical Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.