510(k) · Cleared
ClearedFreespira
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palo Alto Health Sciences, Inc. · HCC Device, Biofeedback
Cleared on Aug 23, 2018 as substantially equivalent to K131586 (Palo Alto Health Sciences, Inc., 2013) after a 213-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it.
- Decided
- Aug 23, 2018
- Review
- 213 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K001359 (2000). 9 ancestors in all, the oldest K993036 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK001359 Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2000 · Recalled
- 5 generations backK020290 Dash 3000/4000 Patient MonitorGeneral Electric Medical Systems Information Techn · 2002 · Recalled
- 4 generations backK030431 Modification to Dash 3000/4000 Patient MonitorGe Medical Systems Information Technologies · 2003 · Recalled
- 3 generations backK042417 Zoll M Series ETC02 Loflo OptionZoll Medical Corp · 2004
- 2 generations backK053174 Loflo C5 CO2 SensorRespironics Novametrix, LLC · 2006 · Recalled
- 1 generation backK131586 Canary Breathing SystemPalo Alto Health Sciences, Inc. · 2013
- This deviceK180173 FreespiraPalo Alto Health Sciences, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK222101 PrismGraymatters Health, Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K222101PrismGraymatters Health, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001359 | Dash 3000/4000 Patient Monitor | General Electric Medical Systems Information Techn | 2000 | 1 |
| −5 | K020290 | Dash 3000/4000 Patient Monitor | General Electric Medical Systems Information Techn | 2002 | 1 |
| −4 | K030431 | Modification to Dash 3000/4000 Patient Monitor | Ge Medical Systems Information Technologies | 2003 | 1 |
| −3 | K042417 | Zoll M Series ETC02 Loflo Option | Zoll Medical Corp | 2004 | — |
| −2 | K053174 | Loflo C5 CO2 Sensor | Respironics Novametrix, LLC | 2006 | 2 |
| −1 | K131586 | Canary Breathing System | Palo Alto Health Sciences, Inc. | 2013 | — |
| 0 (this device) | K180173 | Freespira | Palo Alto Health Sciences, Inc. | 2018 | — |
| +1 | K222101 | Prism | Graymatters Health, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K131586 | Canary Breathing SystemSummary page 5…Device Name / Manufacturer Primary Predicate TM K131586 Canary Breathing System Yes… | 2013 |
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 |
|---|---|---|---|
| K222101 | Prism | 2023 | 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 18 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K222101 (Graymatters Health, Ltd., 2023) has gone furthest, with 0 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. 2018, 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?
Freespira is intended for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of symptoms associated with panic disorder (PD) and/or 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/K180173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180173: Freespira.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180173
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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