Brattle Instrument Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Brattle Instrument Corp.” (first 1977, latest 1981), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 23 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 |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | 3 | 3 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 1 | 1 |
| IXO | Synchronizer, Ecg / Respirator, Radiographic | 1 | 1 |
| IXQ | Table, Radiographic, Stationary Top | 1 | 1 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 1 | 1 |
Review panels
- Obstetrics and Gynecology (4)
- Radiology (2)
- Anesthesiology (1)
Most recent Brattle Instrument Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K810588 | SYNCHRONIZER #208 | IXO | 1981-04-10 | 37 |
| K802978 | TRANSCUTANEOUS BLOOD OXYGEN MONITOR #300 | KLK | 1981-02-02 | 73 |
| K781681 | PHIPIOLOGICAL SYNCHRONIZER PART#205 | IXQ | 1978-10-17 | 15 |
| K770692 | MONITOR, FETAL, NO. L04-1100 | HGM | 1977-04-26 | 12 |
| K770297 | FETAL MONITOR, PART #100-11009 | HGM | 1977-03-09 | 23 |
| K770296 | FETAL MONITOR, PART #101-11009 | HGM | 1977-03-09 | 23 |
| K770295 | ABDOMINAL ECG PROCESSOR FOR FETAL MONI. | HGI | 1977-03-09 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Brattle Instrument Corp..
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 Brattle Instrument Corp.?
FDA lists 7 510(k) clearances under the applicant name “Brattle Instrument Corp.” (first 1977, latest 1981), 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 Brattle Instrument Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Brattle Instrument Corp. is 23 days.
Which FDA product codes appear under Brattle Instrument Corp.?
The most frequent FDA product codes under this applicant name are HGM (System, Monitoring, Perinatal, 3); HGI (Electrocautery, Gynecologic (And Accessories), 1); IXO (Synchronizer, Ecg / Respirator, Radiographic, 1).
Next steps
- See all 7 Brattle Instrument Corp. clearances with predicates and recalls
- Run predicate analysis for product code HGM, Brattle Instrument 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.