510(k) · Cleared
ClearedBiofeedback System/3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davicon, Inc. · HCC Device, Biofeedback
Cleared on Nov 16, 1992 after a 378-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 6 later devices descend from it.
- Decided
- Nov 16, 1992
- Review
- 378 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK914920 Biofeedback System/3Davicon, Inc. · 1992
- Descendant · cites it directly · 4 of its ownK022719 Physical Monitoring Registration UnitMaryrose Cusimano, Ph.D./Phil Reaston · 2002
- Descendant · 2 generations on · 2 of its ownK031995 Comprehensive Neuromuscular ProfilerMedical Technologies Unlimited, Inc. · 2004
- Descendant · 3 generations on · 1 of its ownK113074 Cmap ProMedical Technologies, Inc. · 2012
- Descendant · 4 generations on · 0 of its ownK173510 BioStamp nPointMc10, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK123902 Physical Monitoring Registration Unit-S (Pmru-S)Oktx, LLC · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K022719Physical Monitoring Registration UnitMaryrose Cusimano, Ph.D./Phil Reaston · 2002 · cites it directly4descendants
- K031995Comprehensive Neuromuscular ProfilerMedical Technologies Unlimited, Inc. · 2004 · 2 generations on2descendants
- K113074Cmap ProMedical Technologies, Inc. · 2012 · 3 generations on1descendant
- K173510BioStamp nPointMc10, Inc. · 2018 · 4 generations on0descendants
- K123902Physical Monitoring Registration Unit-S (Pmru-S)Oktx, LLC · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914920 | Biofeedback System/3 | Davicon, Inc. | 1992 | — |
| +1 | K022719 | Physical Monitoring Registration Unit | Maryrose Cusimano, Ph.D./Phil Reaston | 2002 | — |
| +2 | K031995 | Comprehensive Neuromuscular Profiler | Medical Technologies Unlimited, Inc. | 2004 | — |
| +3 | K113074 | Cmap Pro | Medical Technologies, Inc. | 2012 | — |
| +4 | K173510 | BioStamp nPoint | Mc10, Inc. | 2018 | — |
| +2 | K123902 | Physical Monitoring Registration Unit-S (Pmru-S) | Oktx, LLC | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (6)
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?
- Of its descendants, K022719 (Maryrose Cusimano, Ph.D./Phil Reaston, 2002) has gone furthest, with 4 descendants 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 | — |
https://510kreport.com/device/K914920 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914920: Biofeedback System/3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914920
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026