Aeros Instruments, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Aeros Instruments, Inc.” (first 1993, latest 1995), across 1 product code in 1 review panel. Median 510(k) review time under this name: 195 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 |
|---|---|---|---|
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 5 | 5 |
Review panels
Most recent Aeros Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K952103 | AEROS ASPIRATOR | BTA | 1995-07-31 | 88 |
| K933902 | MOBLVAC III | BTA | 1994-05-20 | 283 |
| K934976 | INSTAVAC II | BTA | 1994-05-02 | 195 |
| K932051 | TOTE-L-VAC | BTA | 1993-11-12 | 199 |
| K926566 | CARE-E-VAC | BTA | 1993-07-09 | 190 |
Recalls
openFDA lists no recalls under a recalling firm named Aeros Instruments, 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 Aeros Instruments, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Aeros Instruments, Inc.” (first 1993, latest 1995), 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 Aeros Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aeros Instruments, Inc. is 195 days.
Which FDA product codes appear under Aeros Instruments, Inc.?
The most frequent FDA product codes under this applicant name are BTA (Pump, Portable, Aspiration (Manual Or Powered), 5).
Next steps
- See all 5 Aeros Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BTA, Aeros Instruments, 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.