Aeroceuticals: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Aeroceuticals” (first 1976, latest 1977), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 42 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 |
|---|---|---|---|
| GES | Blade, Scalpel | 4 | 4 |
| KDC | Instrument, Surgical, Disposable | 1 | 1 |
Review panels
Most recent Aeroceuticals 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K770217 | LANCE LTD. STERI. STITCH CUTTER BLADE | GES | 1977-03-30 | 56 |
| K760364 | HANDLE, SCALPEL, STAINLESS STEEL | GES | 1976-09-13 | 42 |
| K760363 | SCALPEL, SURGICAL, STERILE STAINLESS | GES | 1976-09-13 | 42 |
| K760362 | LANCET, BLOOD, STERILE STAINLESS STEEL | KDC | 1976-09-13 | 42 |
| K760361 | BLADE, SURGICAL SCALPEL, STERILE | GES | 1976-09-13 | 42 |
Recalls
openFDA lists no recalls under a recalling firm named Aeroceuticals.
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 Aeroceuticals?
FDA lists 5 510(k) clearances under the applicant name “Aeroceuticals” (first 1976, latest 1977), across 2 product codes 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 Aeroceuticals?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aeroceuticals is 42 days.
Which FDA product codes appear under Aeroceuticals?
The most frequent FDA product codes under this applicant name are GES (Blade, Scalpel, 4); KDC (Instrument, Surgical, Disposable, 1).
Next steps
- See all 5 Aeroceuticals clearances with predicates and recalls
- Run predicate analysis for product code GES, Aeroceuticals'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.