Erie Medical: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Erie Medical” (first 1984, latest 1986), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 266 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 |
|---|---|---|---|
| BTO | Tube, Tracheostomy (W/Wo Connector) | 2 | 2 |
| BTI | Compressor, Air, Portable | 1 | 1 |
| BXH | Gauge, Gas Pressure, Cylinder/Pipeline | 1 | 1 |
| CAN | Regulator, Pressure, Gas Cylinder | 1 | 1 |
Review panels
- Anesthesiology (5)
Most recent Erie Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861865 | ERIE-NEB | BTI | 1986-07-01 | 47 |
| K853051 | TRACHEAL TUBES | BTO | 1986-04-11 | 266 |
| K853039 | PRESSURE REGULATOR | CAN | 1986-04-11 | 266 |
| K853040 | PRESSURE GAUGE | BXH | 1985-10-10 | 83 |
| K832466 | TRACHEAL TUBE 16 GAUGE-1.65MM- | BTO | 1984-09-19 | 421 |
Recalls
openFDA lists no recalls under a recalling firm named Erie Medical.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Erie Controls (1 510(k)s)
- Erie Mfg., Co. (1 510(k)s)
- Erie Scientific Co. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Erie Medical?
FDA lists 5 510(k) clearances under the applicant name “Erie Medical” (first 1984, latest 1986), across 4 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 Erie Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Erie Medical is 266 days.
Which FDA product codes appear under Erie Medical?
The most frequent FDA product codes under this applicant name are BTO (Tube, Tracheostomy (W/Wo Connector), 2); BTI (Compressor, Air, Portable, 1); BXH (Gauge, Gas Pressure, Cylinder/Pipeline, 1).
Next steps
- See all 5 Erie Medical clearances with predicates and recalls
- Run predicate analysis for product code BTO, Erie Medical'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.