Aircast, Inc.: FDA clearances and approvals
Aircast, Inc. has 11 FDA 510(k) clearances (first 1978, latest 2003), across 4 product codes in 2 review panels. Median 510(k) review time: 133 days.
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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 7 | 7 |
| IQI | Orthosis, Limb Brace | 2 | 2 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 | 1 |
| ITQ | Joint, Knee, External Brace | 1 | 1 |
Review panels
- Cardiovascular (7)
- Physical Medicine (4)
Most recent Aircast, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K024019 | ARTERIALFLOW SYSTEM, MODEL 32A | JOW | 2003-06-03 | 180 |
| K023800 | VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODEL 3017 | JOW | 2003-02-10 | 88 |
| K992454 | VENAFLOW SYSTEM, MODEL 30A | JOW | 2000-01-13 | 174 |
| K964238 | AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS | JOW | 1997-09-08 | 320 |
| K961676 | AIRCAST VENAFLOW SYSTEM (MODIFICATION) | JOW | 1997-03-28 | 350 |
| K933977 | AIRCAST EDEMAFLOW SYSTEM | JOW | 1993-12-07 | 116 |
| K932900 | AIRCAST VENAFLOW SYSTEM | JOW | 1993-10-25 | 133 |
| K925677 | AUTOCHILL ACCESSORY KIT | ILO | 1993-04-14 | 272 |
| K812094 | AIRCAST PNEUMATIC KNEE BRACE | ITQ | 1981-08-13 | 20 |
| K810288 | AIRCAST TENNIS ARM BAND | IQI | 1981-02-12 | 10 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aircast, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Aircast, Inc. have?
Aircast, Inc. has 11 FDA 510(k) clearances (first 1978, latest 2003), across 4 product codes in 2 review panels.
How long does FDA take to clear Aircast, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Aircast, Inc.'s cleared 510(k)s is 133 days.
What devices does Aircast, Inc. make?
Its most frequent FDA product codes are JOW (Sleeve, Limb, Compressible, 7); IQI (Orthosis, Limb Brace, 2); ILO (Pack, Hot Or Cold, Water Circulating, 1).
Has Aircast, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Aircast, Inc. Related entities may recall under other names.
Next steps
- See all 11 Aircast, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOW, Aircast, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.