Brentwood Medical Technology Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Brentwood Medical Technology Corp.” (first 2000, latest 2011), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| DPS | Electrocardiograph | 4 | 4 |
| BZG | Spirometer, Diagnostic | 1 | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 1 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 1 | 1 |
Review panels
- Cardiovascular (6)
- Anesthesiology (1)
Most recent Brentwood Medical Technology Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103640 | MIDMARK IQECG | DPS | 2011-03-22 | 99 |
| K100913 | IQVITALS AND IQVITALS SYSTEM | DXN | 2010-05-26 | 55 |
| K052898 | IQMARK EZ STRESS | DPS | 2006-03-28 | 165 |
| K031466 | IQMARK DIGITAL HOLTER | MLO | 2003-06-11 | 34 |
| K013717 | BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY | DPS | 2002-02-06 | 90 |
| K010505 | TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY | DPS | 2001-03-09 | 16 |
| K002499 | BRENTWOOD IQMARK DIGITAL SPIROMETER (INCLUDES DISPOSABLE PNEUMOTACH MOUTHPIECES AND 3-LITER CALIBRATION SYRINGE | BZG | 2000-11-08 | 86 |
Recalls
3 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-05-18.
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.
- Brentwood Instruments, Inc. (21 510(k)s)
- Brentwood Medical Products, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Brentwood Medical Technology Corp.?
FDA lists 7 510(k) clearances under the applicant name “Brentwood Medical Technology Corp.” (first 2000, latest 2011), across 4 product codes in 2 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 Brentwood Medical Technology Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Brentwood Medical Technology Corp. is 86 days.
Which FDA product codes appear under Brentwood Medical Technology Corp.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 4); BZG (Spirometer, Diagnostic, 1); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 1).
Next steps
- See all 7 Brentwood Medical Technology Corp. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Brentwood Medical Technology Corp.'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.