510(k) · Cleared
ClearedMagnes II Biomagnetometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomagnetic Technologies, Inc. · OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Cleared on May 16, 1996 as substantially equivalent to K901215 (Biomagnetic Technologies, Inc., 1990) after a 778-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it.
- Decided
- May 16, 1996
- Review
- 778 days
- Class
- Class II
- Product code
- OLX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K901215 (1990). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK901215 700 Series BiomagnetometerBiomagnetic Technologies, Inc. · 1990
- This deviceK941553 Magnes II BiomagnetometerBiomagnetic Technologies, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK962317 Magnes 2500 WH BiomagnetometerBiomagnetic Technologies, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK152184 MagView BIOMAGNETOMETER SYSTEMTristan Technologies, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK133419 Babymeg Biomagnetometer SystemTristan Technologies, Inc. · 2014
Most influential descendants
Showing 3 of 3 · See all- K962317Magnes 2500 WH BiomagnetometerBiomagnetic Technologies, Inc. · 1997 · cites it directly2descendants
- K152184MagView BIOMAGNETOMETER SYSTEMTristan Technologies, Inc. · 2016 · 2 generations on0descendants
- K133419Babymeg Biomagnetometer SystemTristan Technologies, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K901215 | 700 Series Biomagnetometer | Biomagnetic Technologies, Inc. | 1990 | — |
| 0 (this device) | K941553 | Magnes II Biomagnetometer | Biomagnetic Technologies, Inc. | 1996 | — |
| +1 | K962317 | Magnes 2500 WH Biomagnetometer | Biomagnetic Technologies, Inc. | 1997 | — |
| +2 | K152184 | MagView BIOMAGNETOMETER SYSTEM | Tristan Technologies, Inc. | 2016 | — |
| +2 | K133419 | Babymeg Biomagnetometer System | Tristan Technologies, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OLX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OLX device
- #1 K260563 CN-Suite™score 13.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K901215 | 700 Series Biomagnetometer | 1990 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962317 | Magnes 2500 WH Biomagnetometer | 1997 | 2 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All OLX devicesOLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLX
462in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLX
No recall names OLX since 2007.
Adverse event reports per year · OLX
1in 2015
MAUDE reports naming product code OLX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 462 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Magnes 11 Biomagnetometer is intended for use in diagnostic procedures that
require the measurement and display of exuacranial magnetic ficlds and information
about the electrical activity of the brain as inferred from those fields.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K941553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K941553: Magnes II Biomagnetometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941553
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026