510(k) · Cleared
ClearedNtrainer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kcbiomedix, Inc. · HCC Device, Biofeedback
Cleared on Feb 1, 2008 as substantially equivalent to K010388 (Ohmeda Medical, 2001) and 1 other predicate after a 210-day review. Its family tree reaches back 2 generations to 1995. 1 later device descends from it.
- Decided
- Feb 1, 2008
- Review
- 210 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951213 (1995). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK951213 RelaxplusUltramind International, Ltd. · 1995
- 1 generation backK980373 Ultramind Biofeedback System with DE-Stress SoftwareUltramind International, Ltd. · 1998
- This deviceK071866 Ntrainer SystemKcbiomedix, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK143507 NFANT Feeding SolutionNfant Labs, LLC · 2015
Most influential descendants
Showing 1 of 1 · See all- K143507NFANT Feeding SolutionNfant Labs, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951213 | Relaxplus | Ultramind International, Ltd. | 1995 | — |
| −1 | K980373 | Ultramind Biofeedback System with DE-Stress Software | Ultramind International, Ltd. | 1998 | — |
| 0 (this device) | K071866 | Ntrainer System | Kcbiomedix, Inc. | 2008 | — |
| +1 | K143507 | NFANT Feeding Solution | Nfant Labs, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K010388 | Sondrex P.a.L. SystemSummary page 1…* Classification Name - Biofeedback device (21 CFR 882.5050, Product Code - HCC) Predicate Devices There are two predicate devices. The Sondrex P.A.L System (K010388) is a pacifier system and method for reinforcing non-nutritive sucking (NNS) of premature infants and the Ultramind Biofeedback S… | 2001 |
| * | K980373 | Ultramind Biofeedback System with DE-Stress SoftwareSummary page 1…The Sondrex P.A.L System (K010388) is a pacifier system and method for reinforcing non-nutritive sucking (NNS) of premature infants and the Ultramind Biofeedback System (K980373) is an apparatus and software designed to train the user to control one or more aspects of their psycho-physiological state inclu… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143507 | NFANT Feeding Solution | 2015 | 0 |
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 13 years and passes through 2 companies; a new generation was cleared every 9.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K143507 (Nfant Labs, LLC, 2015) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K010388.
How does its category compare?
All HCC devicesHCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 NTrainer System reinforces non-nutritive suck (NNS) in newborns and infants born
prematurely.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071866 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071866: Ntrainer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071866
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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