510(k) · Cleared
ClearedUltramind Biofeedback System with DE-Stress Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultramind International, Ltd. · HCC Device, Biofeedback
Cleared on Apr 29, 1998 as substantially equivalent to K951213 (Ultramind International, Ltd., 1995) after an 89-day review. Its family tree reaches back 1 generation to 1995. 2 later devices descend from it.
- Decided
- Apr 29, 1998
- Review
- 89 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951213 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK951213 RelaxplusUltramind International, Ltd. · 1995
- This deviceK980373 Ultramind Biofeedback System with DE-Stress SoftwareUltramind International, Ltd. · 1998
- Descendant · cites it directly · 1 of its ownK071866 Ntrainer SystemKcbiomedix, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK143507 NFANT Feeding SolutionNfant Labs, LLC · 2015
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 |
|---|---|---|---|---|---|
| −1 | K951213 | Relaxplus | Ultramind International, Ltd. | 1995 | — |
| 0 (this device) | K980373 | Ultramind Biofeedback System with DE-Stress Software | Ultramind International, Ltd. | 1998 | — |
| +1 | K071866 | Ntrainer System | Kcbiomedix, Inc. | 2008 | — |
| +2 | K143507 | NFANT Feeding Solution | Nfant Labs, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2015 | 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 HCC? 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 HCC device
- #1 K233580 A Breathing System (ABS)score 8.1 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K951213 | RelaxplusSummary page 2…ices as a class II device (product code 84 HCC) and it is reviewed by the Neurology Devices Branch. 7-3 Predicate Devices: Ultramind RelaxPlus™ System (K951213) Performance Standards: No performance standards applicable to the biofeedback devices have been established under Sections 514… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071866 | Ntrainer System | 2008 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K071866 (Kcbiomedix, Inc., 2008) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HCC devicesHCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HCC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HCC
Too few HCC 510(k)s in any year since 2007 to give a median.
Recalls per year · HCC
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HCC
5in 2024
MAUDE reports naming product code HCC, 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 | 2 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ultramind Biofeedback System with de-STRESS Software is a biofeedback system designed to be used for relaxation training.
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/K980373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980373: Ultramind Biofeedback System with DE-Stress Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980373
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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