510(k) · Cleared
ClearedDayspring
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Koya Medical, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Apr 23, 2021 as substantially equivalent to K193288 (Koya, Inc., 2020) and 1 other predicate after a 29-day review. Its family tree reaches back 9 generations to 1995. 4 later devices descend from it.
- Decided
- Apr 23, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K944567 (1995). 20 ancestors in all, the oldest K914774 (1992). 4 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 5 generations between
- 3 generations backK153311 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016
- 2 generations backK170216 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2017
- 1 generation backK193288 Koya RippleKoya, Inc. · 2020
- This deviceK210885 DayspringKoya Medical, Inc. · 2021
- Descendant · cites it directly · 1 of its ownK223228 DayspringKoya Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK253555 Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical · 2026
- Descendant · cites it directly · 0 of its ownK222823 AeroDVx Arm SystemSun Scientific, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK212287 Dayspring LiteKoya Medical, Inc. · 2021
Show all 9 generations
- Root · 9 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 8 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 7 generations backK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
- 6 generations backK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
- 5 generations backK062818 Flexitouch SystemTactile Systems Technology, Inc. · 2006
- 4 generations backK120972 Flexitouch SystemTactile Systems Technology, Inc. · 2012
- 3 generations backK153311 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016
- 2 generations backK170216 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2017
- 1 generation backK193288 Koya RippleKoya, Inc. · 2020
- This deviceK210885 DayspringKoya Medical, Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K223228DayspringKoya Medical, Inc. · 2024 · cites it directly1descendant
- K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical · 2026 · 2 generations on0descendants
- K222823AeroDVx Arm SystemSun Scientific, Inc. · 2023 · cites it directly0descendants
- K212287Dayspring LiteKoya Medical, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −8 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −7 | K993758 | Proair 3000 Compression System | Medical Compression Systems (Dbn), Ltd. | 2000 | — |
| −6 | K060146 | Activecare ++ System | Medical Compression Systems (Dbn), Ltd. | 2006 | 1 |
| −5 | K062818 | Flexitouch System | Tactile Systems Technology, Inc. | 2006 | — |
| −4 | K120972 | Flexitouch System | Tactile Systems Technology, Inc. | 2012 | — |
| −3 | K153311 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2016 | — |
| −2 | K170216 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2017 | — |
| −1 | K193288 | Koya Ripple | Koya, Inc. | 2020 | — |
| 0 (this device) | K210885 | Dayspring | Koya Medical, Inc. | 2021 | — |
| +1 | K223228 | Dayspring | Koya Medical, Inc. | 2024 | — |
| +2 | K253555 | Flexitouch® Plus Advanced Pneumatic Compression System | Tactile Medical | 2026 | — |
| +1 | K222823 | AeroDVx Arm System | Sun Scientific, Inc. | 2023 | — |
| +1 | K212287 | Dayspring Lite | Koya Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 JOW? 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 JOW device
- #1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 |
|---|---|---|---|
| * | K193288 | Koya RippleSummary page 4…W III. PREDICATE DEVICES: Primary Predicate Manufacturer: Koya Medical, Inc. Trade Name: Koya Dayspring 510(k): K193288 Additional Predicate Manufacturer: Tactile Systems Technology, Inc. Trade Name: Flexitouch Pl… | 2020 |
| * | K203178 | Flexitouch Plus SystemSummary page 4…tional Predicate Manufacturer: Tactile Systems Technology, Inc. Trade Name: Flexitouch Plus System (PD32-G3) 510(k): K203178 IV. DEVICE DESCRIPTION: The Dayspring system consists of two main components: a controller and garment. The garment is powered… | 2020 |
What descends from it? (4)
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?
- The line of descent spans 26 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K223228 (Koya Medical, Inc., 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · JOW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOW
168in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOW
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOW
24in 2025
MAUDE reports naming product code JOW, 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 | 6 | 66 | 0 | 12 |
| 2008 | 4 | 112 | 7 | 36 |
| 2009 | 3 | 84 | 0 | 45 |
| 2010 | 18 | 71 | 2 | 66 |
| 2011 | 11 | 104 | 3 | 50 |
| 2012 | 13 | 63 | 2 | 100 |
| 2013 | 17 | 94 | 0 | 169 |
| 2014 | 16 | 91 | 0 | 93 |
| 2015 | 10 | 160 | 0 | 137 |
| 2016 | 9 | 121 | 0 | 150 |
| 2017 | 9 | 116 | 1 | 149 |
| 2018 | 11 | 136 | 0 | 114 |
| 2019 | 11 | 88 | 1 | 102 |
| 2020 | 14 | 158 | 0 | 50 |
| 2021 | 16 | 132 | 0 | 34 |
| 2022 | 7 | 80 | 0 | 27 |
| 2023 | 6 | 160 | 0 | 57 |
| 2024 | 8 | 197 | 0 | 30 |
| 2025 | 7 | 168 | 0 | 24 |
| 2026 | 6 | 252 | 0 | — |
What is it indicated for?
The Koya Dayspring system is a prescription only wearable compression system that is intended for use in a clinic or home setting by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as: • Lymphedema • Primary lymphedema • Post mastectomy edema • Edema following trauma and sports injuries • Post immobilization edema • Venous insufficiency • Reducing wound healing time…
Read the full statement (112 words)
The Koya Dayspring system is a prescription only wearable compression system that is intended for use in a clinic or home setting by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as:
• Lymphedema
• Primary lymphedema
• Post mastectomy edema
• Edema following trauma and sports injuries
• Post immobilization edema
• Venous insufficiency
• Reducing wound healing time
• Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers
• Lipedema
• Phlebolymphedema
The Dayspring system is developed on a wearable compression technology platform, which is designed to provide mobility for patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210885 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210885: Dayspring.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210885
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