510(k) · Cleared
ClearedBabymeg Biomagnetometer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tristan Technologies, Inc. · OLY Magnetoencephalograph
Cleared on Jul 21, 2014 as substantially equivalent to K962317 (Biomagnetic Technologies, Inc., 1997) after a 256-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Jul 21, 2014
- Review
- 256 days
- Class
- Class II
- Product code
- OLY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K901215 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK901215 700 Series BiomagnetometerBiomagnetic Technologies, Inc. · 1990
- 2 generations backK941553 Magnes II BiomagnetometerBiomagnetic Technologies, Inc. · 1996
- 1 generation backK962317 Magnes 2500 WH BiomagnetometerBiomagnetic Technologies, Inc. · 1997
- This deviceK133419 Babymeg Biomagnetometer SystemTristan Technologies, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901215 | 700 Series Biomagnetometer | Biomagnetic Technologies, Inc. | 1990 | — |
| −2 | K941553 | Magnes II Biomagnetometer | Biomagnetic Technologies, Inc. | 1996 | — |
| −1 | K962317 | Magnes 2500 WH Biomagnetometer | Biomagnetic Technologies, Inc. | 1997 | — |
| 0 (this device) | K133419 | Babymeg Biomagnetometer System | Tristan Technologies, Inc. | 2014 | — |
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 |
|---|---|---|---|
| * | K962317 | Magnes 2500 WH BiomagnetometerSummary page 2…r is substantially equivalent to the Magncs 2500 WH Biomagnetometer System formerly manufactured and marketed by Biomagnetic Technologies, Inc., San Diego, CA. K9623 17 4. Description of Device: The Tristan Technologies Artemis 123 Biomagnetometer (hereinafter referred to as the "A… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K962317.
How does its category compare?
All OLY devicesOLY Magnetoencephalograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 Artemis 123 Biomnagnetometer 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/K133419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133419: Babymeg Biomagnetometer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133419
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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