Aci Medical, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Aci Medical, Inc.” (first 1985, latest 2014), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 200 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 | 1 | 293 |
| 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 3 | 3 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 | 1 |
| DSB | Plethysmograph, Impedance | 1 | 1 |
| FLN | Monitor, Electric For Gravity Flow Infusion Systems | 1 | 1 |
| LLK | Legging, Compression, Non-Inflatable | 1 | 1 |
Review panels
- Cardiovascular (4)
- General Hospital (2)
- Anesthesiology (1)
Most recent Aci Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131146 | ARTASSIST AND VENASSIST | JOW | 2014-02-10 | 293 |
| K942530 | ART-ASSIST MODEL AA-1000 | JOW | 1996-02-28 | 642 |
| K903894 | VENAPULSE MODELS VP-25 AND VP-50 | JOW | 1991-04-03 | 223 |
| K903532 | UNNA-SLEEVE(TM) | LLK | 1990-11-02 | 88 |
| K881291 | AIR PLETHYSMOGRAPH MODEL APG-1000 | DSB | 1988-10-14 | 200 |
| K861645 | MICRO-TRACHEOSTOMY CARE KIT | BTO | 1986-05-09 | 9 |
| K844309 | IV RATEMETER | FLN | 1985-01-22 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Aci 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 Aci Medical, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Aci Medical, Inc.” (first 1985, latest 2014), across 5 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 Aci Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aci Medical, Inc. is 200 days.
Which FDA product codes appear under Aci Medical, Inc.?
The most frequent FDA product codes under this applicant name are JOW (Sleeve, Limb, Compressible, 3); BTO (Tube, Tracheostomy (W/Wo Connector), 1); DSB (Plethysmograph, Impedance, 1).
Next steps
- See all 7 Aci Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOW, Aci 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.