Aed Battery Exchange, LLC: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Aed Battery Exchange, LLC” (first 2012, latest 2012), plus 1 PMA decision, across 1 product code in 1 review panel. Median 510(k) review time under this name: 269 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 | 1 | 269 |
| 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 |
|---|---|---|---|
| MKJ | Automated External Defibrillators (Non-Wearable) | 2 | 1 |
Review panels
- Cardiovascular (2)
Most recent Aed Battery Exchange, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120350 | EXTENDED LIFE BATTERY | MKJ | 2012-11-01 | 269 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P190013 | PMA | AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) | 2021-02-02 |
Recalls
openFDA lists no recalls under a recalling firm named Aed Battery Exchange, LLC.
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 Aed Battery Exchange, LLC?
FDA lists 1 510(k) clearance under the applicant name “Aed Battery Exchange, LLC” (first 2012, latest 2012), plus 1 PMA 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 Aed Battery Exchange, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aed Battery Exchange, LLC is 269 days.
Which FDA product codes appear under Aed Battery Exchange, LLC?
The most frequent FDA product codes under this applicant name are MKJ (Automated External Defibrillators (Non-Wearable), 2).
Next steps
- See all 1 Aed Battery Exchange, LLC clearances with predicates and recalls
- Run predicate analysis for product code MKJ, Aed Battery Exchange, LLC'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.