510(k) · Cleared
ClearedResperate; Model RR-150
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intercure, Ltd. · HCC Device, Biofeedback
Cleared on Jul 2, 2002 as substantially equivalent to K000405 (Intercure, Ltd., 2000) after a 146-day review. Its family tree reaches back 1 generation to 2000. 5 later devices descend from it.
- Decided
- Jul 2, 2002
- Review
- 146 days
- Class
- Class II
- Product code
- HCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000405 (2000). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK000405 Intercure LTD. Respi-LowIntercure, Ltd. · 2000
- This deviceK020399 Resperate; Model RR-150Intercure, Ltd. · 2002
- Descendant · cites it directly · 2 of its ownK131586 Canary Breathing SystemPalo Alto Health Sciences, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK180173 FreespiraPalo Alto Health Sciences, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK233580 A Breathing System (ABS)Deepwell Dtx, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK222101 PrismGraymatters Health, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK070467 Health MaskPolar Wrap, LLC · 2007
Most influential descendants
Showing 5 of 5 · See all- K131586Canary Breathing SystemPalo Alto Health Sciences, Inc. · 2013 · cites it directly2descendants
- K180173FreespiraPalo Alto Health Sciences, Inc. · 2018 · 2 generations on1descendant
- K233580A Breathing System (ABS)Deepwell Dtx, Inc. · 2024 · cites it directly0descendants
- K222101PrismGraymatters Health, Ltd. · 2023 · 3 generations on0descendants
- K070467Health MaskPolar Wrap, LLC · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000405 | Intercure LTD. Respi-Low | Intercure, Ltd. | 2000 | — |
| 0 (this device) | K020399 | Resperate; Model RR-150 | Intercure, Ltd. | 2002 | — |
| +1 | K131586 | Canary Breathing System | Palo Alto Health Sciences, Inc. | 2013 | — |
| +2 | K180173 | Freespira | Palo Alto Health Sciences, Inc. | 2018 | — |
| +1 | K233580 | A Breathing System (ABS) | Deepwell Dtx, Inc. | 2024 | — |
| +3 | K222101 | Prism | Graymatters Health, Ltd. | 2023 | — |
| +1 | K070467 | Health Mask | Polar Wrap, LLC | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K000405 | Intercure LTD. Respi-Low Our reading of the summary gave K000495, FDA’s number for Ballard Medical Products Epidural and Spinal Needles (Ballard Medical Products). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Respi-Low Model RL-108”. | 2000 |
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?
- Its one ancestor has no recall.
- Of its descendants, K131586 (Palo Alto Health Sciences, Inc., 2013) has gone furthest, with 2 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 | — |
What is it indicated for?
The RXSPeRATE is intended for use as a relaxation treatment for the reduction of stress by leading the user through interactively guided and monitored breathing exercises. The device is indicated for use only as an adjunctive treatment for high blood pressure, together with other pharmacological and/or non-pharmacological interventions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020399 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020399: Resperate; Model RR-150.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020399
Report an extraction error
Are you the manufacturer?
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