Airxpanders, Inc.: FDA filings under this applicant name
FDA lists 2 510(k) clearances under the applicant name “Airxpanders, Inc.” (first 2017, latest 2019), plus 1 De Novo decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 78 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 |
|---|---|---|
| 2017 | 1 | 84 |
| 2018 | 0 | — |
| 2019 | 1 | 72 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Airxpanders, Inc. took a median 78 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 78 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PQN | Carbon Dioxide Gas Controlled Tissue Expander | 3 | 2 |
Review panels
Most recent Airxpanders, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K191138 | AeroForm Tissue Expander, Smooth | PQN | 2019-07-11 | 72 |
| K170075 | AeroForm Tissue Expander (v3.0), AeroForm Dosage Controller (v1.5) | PQN | 2017-04-03 | 84 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN150055 | De Novo | Carbon Dioxide Gas Controlled Tissue Expander | 2016-12-21 |
Recalls
openFDA lists no recalls under a recalling firm named Airxpanders, 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.
Device clinical trials
An industry sponsor named Airxpanders, Inc. is the lead sponsor of 4 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02504424: AirXpanders AeroForm Tissue Expander System for Breast Reconstruction (Completed, started 2015-11-12)
- NCT01903174: Study of AeroForm Tissue Expander for Breast Reconstruction (Completed, started 2012-06)
- NCT01425268: Patient Controlled Tissue Expansion for Breast Reconstruction (Completed, started 2011-10)
- NCT01009008: Patient Activated Controlled Expansion (PACE) Trial (Completed, started 2009-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Airxpanders, Inc.?
FDA lists 2 510(k) clearances under the applicant name “Airxpanders, Inc.” (first 2017, latest 2019), plus 1 De Novo decision, across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Airxpanders, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Airxpanders, Inc. is 78 days.
Which FDA product codes appear under Airxpanders, Inc.?
The most frequent FDA product codes under this applicant name are PQN (Carbon Dioxide Gas Controlled Tissue Expander, 3).
Next steps
- See all 2 Airxpanders, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PQN, Airxpanders, 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.