Aries Medical, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Aries Medical, Inc.” (first 1984, latest 1991), across 8 product codes in 3 review panels. Median 510(k) review time under this name: 130 days. 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 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | 8 | 8 |
| DYB | Introducer, Catheter | 4 | 4 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 2 | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 | 1 |
| BSP | Needle, Conduction, Anesthetic (W/Wo Introducer) | 1 | 1 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 1 | 1 |
| MJL | Eia, Blastomyces Dermatitidis | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (15)
- Anesthesiology (2)
- Microbiology (1)
Most recent Aries Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K912604 | SJM/CAD ISOFLOW(TM) CENTRIFUGAL PUMP 2100CP, MODIF | KFM | 1991-10-28 | 150 |
| K903925 | ARIES MELDICAL MODEL 2100HC HANK CRANK | KFM | 1990-12-21 | 130 |
| K903442 | ARIES TAPERSEAL(TM) SHEATH | DYB | 1990-08-23 | 23 |
| K895433 | ARIES 30CC & 50CC INTRA-AORTIC BALLOON & CONT. SYS | DSP | 1990-04-10 | 215 |
| K882289 | ARIES 40CC PERCU. (D/L) INTRA-AORTIC BALLOON CATH. | DSY | 1988-12-12 | 194 |
| K864994 | 40CC PER. PRE-FURL (S/L) INTRA-AORTIC CATHETER | DSP | 1987-06-19 | 179 |
| K864537 | 40CC PERCUTANEOUS PRE-FURL (D/L) BALLOON CATHETER | DSP | 1987-06-19 | 214 |
| K864568 | 40CC SURGICAL DOUBLE LUMEN BALLOON CATHETER | DSP | 1987-05-12 | 174 |
| K864567 | 40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER | DSP | 1987-05-12 | 174 |
| K871140 | ARIES PEEL AWAY PERCUTANEOUS CATHETER INTRODUCER | DYB | 1987-04-22 | 30 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aries Medical, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Aries Medical, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Aries Medical, Inc.” (first 1984, latest 1991), across 8 product codes in 3 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 Aries Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aries Medical, Inc. is 130 days.
Which FDA product codes appear under Aries Medical, Inc.?
The most frequent FDA product codes under this applicant name are DSP (System, Balloon, Intra-Aortic And Control, 8); DYB (Introducer, Catheter, 4); KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type, 2).
Next steps
- See all 19 Aries Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSP, Aries Medical, 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.