Biomagnetic Technologies, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Biomagnetic Technologies, Inc.” (first 1979, latest 1999), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 110 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 |
|---|---|---|---|
| OLX | Source Localization Software For Electroencephalograph Or Magnetoencephalograph | 3 | 3 |
| OLY | Magnetoencephalograph | 2 | 2 |
| CBK | Ventilator, Continuous, Facility Use | 1 | 1 |
| GZP | Stimulator, Mechanical, Evoked Response | 1 | 1 |
Plus 1 more product codes.
Review panels
- Neurology (6)
- Anesthesiology (1)
Most recent Biomagnetic Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993708 | BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG | OLX | 1999-12-03 | 30 |
| K962317 | MAGNES 2500 WH BIOMAGNETOMETER | OLY | 1997-05-07 | 324 |
| K941553 | MAGNES II BIOMAGNETOMETER | OLX | 1996-05-16 | 778 |
| K921821 | IBT MODEL SVI | CBK | 1992-11-02 | 200 |
| K913604 | SOMATOSENSORY STIMULUS SYSTEM | GZP | 1991-12-09 | 117 |
| K901215 | 700 SERIES BIOMAGNETOMETER | OLX | 1990-06-25 | 103 |
| K854466 | BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER | OLY | 1986-02-04 | 90 |
| K790031 | GENERATOR, BIOTEC 876 PULSE | — | 1979-01-02 | 0 |
Recalls
openFDA lists no recalls under a recalling firm named Biomagnetic Technologies, Inc..
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 Biomagnetic Technologies, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Biomagnetic Technologies, Inc.” (first 1979, latest 1999), across 5 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 Biomagnetic Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomagnetic Technologies, Inc. is 110 days.
Which FDA product codes appear under Biomagnetic Technologies, Inc.?
The most frequent FDA product codes under this applicant name are OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph, 3); OLY (Magnetoencephalograph, 2); CBK (Ventilator, Continuous, Facility Use, 1).
Next steps
- See all 8 Biomagnetic Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OLX, Biomagnetic Technologies, Inc.'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.