510(k) · Cleared
ClearedMagnes 2500 WH Biomagnetometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomagnetic Technologies, Inc. · OLY Magnetoencephalograph
Cleared on May 7, 1997 as substantially equivalent to K941553 (Biomagnetic Technologies, Inc., 1996) after a 324-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it.
- Decided
- May 7, 1997
- Review
- 324 days
- Class
- Class II
- Product code
- OLY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K901215 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK901215 700 Series BiomagnetometerBiomagnetic Technologies, Inc. · 1990
- 1 generation backK941553 Magnes II BiomagnetometerBiomagnetic Technologies, Inc. · 1996
- This deviceK962317 Magnes 2500 WH BiomagnetometerBiomagnetic Technologies, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK152184 MagView BIOMAGNETOMETER SYSTEMTristan Technologies, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK133419 Babymeg Biomagnetometer SystemTristan Technologies, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901215 | 700 Series Biomagnetometer | Biomagnetic Technologies, Inc. | 1990 | — |
| −1 | K941553 | Magnes II Biomagnetometer | Biomagnetic Technologies, Inc. | 1996 | — |
| 0 (this device) | K962317 | Magnes 2500 WH Biomagnetometer | Biomagnetic Technologies, Inc. | 1997 | — |
| +1 | K152184 | MagView BIOMAGNETOMETER SYSTEM | Tristan Technologies, Inc. | 2016 | — |
| +1 | K133419 | Babymeg Biomagnetometer System | Tristan Technologies, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 OLY? 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 OLY device
- #1 K191785 Orion LifeSpan MEGscore 0.0 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K941553 | Magnes II BiomagnetometerSummary page 1…00 biomagnetometer 3. Substantial equivalence is claimed to the Magnes II biomagnetometer, manufactured and marketed by Biomagnetic Technologies, Inc. (Reference 510(k) K941553) 4, Description of Device: The Magnes 2500 WH biomagnetometer (hereafter "Magnes 2500 WH") comprises a magnetic sensor for detec… | 1996 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 5.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K152184 (Tristan Technologies, Inc., 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OLY devicesOLY Magnetoencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OLY
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · OLY
Too few OLY 510(k)s in any year since 2007 to give a median.
Recalls per year · OLY
No recall names OLY since 2007.
Adverse event reports per year · OLY
1in 2012
MAUDE reports naming product code OLY, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Use of the Magnes 2500 WH is indicated for the patient whose physician believes that information about the magnetic fields produced by that patient's brain and information about the location of the sources of those magnetic fields could contribute to diagnosis or therapy planning.
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/K962317 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962317: Magnes 2500 WH Biomagnetometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962317
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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