Baltimore Therapeutic Equipment Co.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Baltimore Therapeutic Equipment Co.” (first 1980, latest 1995), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 165 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 |
|---|---|---|---|
| BXB | Exerciser, Powered | 3 | 3 |
| IKK | System, Isokinetic Testing And Evaluation | 1 | 1 |
| ISD | Exerciser, Measuring | 1 | 1 |
| KQX | Goniometer, Ac-Powered | 1 | 1 |
| LXW | Column, Adsorption, Low Density, Lipoprotein | 1 | 1 |
Review panels
Most recent Baltimore Therapeutic Equipment Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955106 | BTE CPM-20 | BXB | 1995-12-29 | 51 |
| K955105 | BTE CPM-10 | BXB | 1995-12-29 | 51 |
| K925225 | THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK | KQX | 1994-06-27 | 619 |
| K933611 | THE BTE WS30 | ISD | 1994-06-20 | 336 |
| K924414 | THE BTE DYNAMIC LIFT | IKK | 1993-02-12 | 165 |
| K895881 | MOTIONSPECT | LXW | 1990-04-10 | 187 |
| K800007 | WORK SIMULATOR | BXB | 1980-01-21 | 18 |
Recalls
openFDA lists no recalls under a recalling firm named Baltimore Therapeutic Equipment Co..
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 Baltimore Therapeutic Equipment Co.?
FDA lists 7 510(k) clearances under the applicant name “Baltimore Therapeutic Equipment Co.” (first 1980, latest 1995), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Baltimore Therapeutic Equipment Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Baltimore Therapeutic Equipment Co. is 165 days.
Which FDA product codes appear under Baltimore Therapeutic Equipment Co.?
The most frequent FDA product codes under this applicant name are BXB (Exerciser, Powered, 3); IKK (System, Isokinetic Testing And Evaluation, 1); ISD (Exerciser, Measuring, 1).
Next steps
- See all 7 Baltimore Therapeutic Equipment Co. clearances with predicates and recalls
- Run predicate analysis for product code BXB, Baltimore Therapeutic Equipment Co.'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.