510(k) · Cleared
ClearedFlexcomp DSP & Procomp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thought Technology, Ltd. · HCC Device, Biofeedback
Cleared on Feb 12, 1991 after a 193-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 12, 1991
- Review
- 193 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK903497 Flexcomp DSP & ProcompThought Technology, Ltd. · 1991
- Descendant · cites it directly · 3 of its ownK073557 Eeg Neuroamp, Model CS10137Corscience GmbH & Co. KG · 2008 · Recalled
- Descendant · cites it directly · 1 of its ownK122879 EEGER4 Model 4.3Eeg Software, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK222101 PrismGraymatters Health, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK193159 NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG · 2020
- Descendant · cites it directly · 0 of its ownK142551 QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC · 2015
Most influential descendants
Showing 5 of 5 · See all- K073557Eeg Neuroamp, Model CS10137Corscience GmbH & Co. KG · 2008 · cites it directly3descendants
- K122879EEGER4 Model 4.3Eeg Software, LLC · 2013 · cites it directly1descendant
- K222101PrismGraymatters Health, Ltd. · 2023 · 2 generations on0descendants
- K193159NeuroAmp II, NeuroAmp II.5sCorscience GmbH & Co. KG · 2020 · 2 generations on0descendants
- K142551QANS (Quantitative Autonomic Nervous System) Monitoring SystemHhssystems, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903497 | Flexcomp DSP & Procomp | Thought Technology, Ltd. | 1991 | — |
| +1 | K073557 | Eeg Neuroamp, Model CS10137 | Corscience GmbH & Co. KG | 2008 | 1 |
| +1 | K122879 | EEGER4 Model 4.3 | Eeg Software, LLC | 2013 | — |
| +2 | K222101 | Prism | Graymatters Health, Ltd. | 2023 | — |
| +2 | K193159 | NeuroAmp II, NeuroAmp II.5s | Corscience GmbH & Co. KG | 2020 | — |
| +1 | K142551 | QANS (Quantitative Autonomic Nervous System) Monitoring System | Hhssystems, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
3 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, K073557 (Corscience GmbH & Co. KG, 2008) has gone furthest, with 3 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/K903497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K903497: Flexcomp DSP & Procomp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K903497
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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