510(k) · Cleared
ClearedPrism
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Graymatters Health, Ltd. · HCC Device, Biofeedback
Cleared on Mar 17, 2023 as substantially equivalent to K122879 (Eeg Software, LLC, 2013) and 1 other predicate after a 242-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Mar 17, 2023
- Review
- 242 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K001359 (2000). 17 ancestors in all, the oldest K903497 (1991). No later device cites it as a predicate yet.
- Root · 7 generations backK001359 Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2000 · Recalled
- 6 generations backK020290 Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- 5 generations backK030431 Modification to Dash 3000/4000 Patient MonitorGe Medical Systems Information Technologies · 2003 · Recalled
- 4 generations backK042417 Zoll M Series ETC02 Loflo OptionZoll Medical Corp · 2004
- 3 generations backK053174 Loflo C5 CO2 SensorRespironics Novametrix, LLC · 2006 · Recalled
- 2 generations backK131586 Canary Breathing SystemPalo Alto Health Sciences, Inc. · 2013
- 1 generation backK180173 FreespiraPalo Alto Health Sciences, Inc. · 2018
- This deviceK222101 PrismGraymatters Health, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001359 | Dash 3000/4000 Patient Monitor | General Electric Medical Systems Information Techn | 2000 | 1 |
| −6 | K020290 | Dash 3000/4000 Patient Monitor | General Electric Medical Systems Information Techn | 2002 | 1 |
| −5 | K030431 | Modification to Dash 3000/4000 Patient Monitor | Ge Medical Systems Information Technologies | 2003 | 1 |
| −4 | K042417 | Zoll M Series ETC02 Loflo Option | Zoll Medical Corp | 2004 | — |
| −3 | K053174 | Loflo C5 CO2 Sensor | Respironics Novametrix, LLC | 2006 | 2 |
| −2 | K131586 | Canary Breathing System | Palo Alto Health Sciences, Inc. | 2013 | — |
| −1 | K180173 | Freespira | Palo Alto Health Sciences, Inc. | 2018 | — |
| 0 (this device) | K222101 | Prism | Graymatters Health, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 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
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 |
|---|---|---|---|
| * | K122879 | EEGER4 Model 4.3Summary page 4…ICE IDENTIFICATION Prism is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Predicate K122879 EEGer4 / EEG Software LLC. Primary Predicate K180173 Freespira / Palo Alto… | 2013 |
| * | K180173 | FreespiraSummary page 4…r Predicate Device Name / Manufacturer Predicate K122879 EEGer4 / EEG Software LLC. Primary Predicate K180173 Freespira / Palo Alto Health Sciences, Inc. Secondary Predicate The predicate devices have not been subje… | 2018 |
| † | K171669 | g.Nautilus PRO | 2017 |
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 23 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 17 ancestors have a recall of any class.
How does its category compare?
All HCC devicesHCC Device, Biofeedback: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Prism is a neurofeedback software device intended for relaxation and stress reduction through the use of EEG biofeedback. The device is indicated as an adjunctive treatment of symptoms associated with posttraumatic stress disorder (PTSD), to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222101: Prism.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222101
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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