510(k) · Cleared
ClearedDayspring Lite
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 Sep 21, 2021 as substantially equivalent to K210885 (Koya Medical, Inc., 2021) and 1 other predicate after a 62-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Sep 21, 2021
- Review
- 62 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K944567 (1995). 34 ancestors in all, the oldest K810338 (1981). No later device cites it as a predicate yet.
- Root · 10 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 6 generations between
- 3 generations backK170216 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2017
- 2 generations backK193288 Koya RippleKoya, Inc. · 2020
- 1 generation backK210885 DayspringKoya Medical, Inc. · 2021
- This deviceK212287 Dayspring LiteKoya Medical, Inc. · 2021
Show all 10 generations
- Root · 10 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 9 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 8 generations backK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
- 7 generations backK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
- 6 generations backK062818 Flexitouch SystemTactile Systems Technology, Inc. · 2006
- 5 generations backK120972 Flexitouch SystemTactile Systems Technology, Inc. · 2012
- 4 generations backK153311 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2016
- 3 generations backK170216 Flexitouch SystemTactile Systems Technology, Inc. (Dba Tactile Medical) · 2017
- 2 generations backK193288 Koya RippleKoya, Inc. · 2020
- 1 generation backK210885 DayspringKoya Medical, Inc. · 2021
- This deviceK212287 Dayspring LiteKoya Medical, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −9 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −8 | K993758 | Proair 3000 Compression System | Medical Compression Systems (Dbn), Ltd. | 2000 | — |
| −7 | K060146 | Activecare ++ System | Medical Compression Systems (Dbn), Ltd. | 2006 | 1 |
| −6 | K062818 | Flexitouch System | Tactile Systems Technology, Inc. | 2006 | — |
| −5 | K120972 | Flexitouch System | Tactile Systems Technology, Inc. | 2012 | — |
| −4 | K153311 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2016 | — |
| −3 | K170216 | Flexitouch System | Tactile Systems Technology, Inc. (Dba Tactile Medical) | 2017 | — |
| −2 | K193288 | Koya Ripple | Koya, Inc. | 2020 | — |
| −1 | K210885 | Dayspring | Koya Medical, Inc. | 2021 | — |
| 0 (this device) | K212287 | Dayspring Lite | Koya Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 3 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K210885 | DayspringSummary page 4…COMPRESSIBLE LIMB SLEEVE (21 CFR 870.5800) DEVICE CLASSIFICATION: CLASS II PRODUCT CODE: JOW III. PREDICATE DEVICES: K143185, K210885 IV. DEVICE DESCRIPTION: Dayspring Lite consists of two main components: a controller and garment. The garment is powered by a… | 2021 |
| * | K143185 | entré Model PD08-USummary page 4…N NAME: COMPRESSIBLE LIMB SLEEVE (21 CFR 870.5800) DEVICE CLASSIFICATION: CLASS II PRODUCT CODE: JOW III. PREDICATE DEVICES: K143185, K210885 IV. DEVICE DESCRIPTION: Dayspring Lite consists of two main components: a controller and garment. The garment is pow… | 2015 |
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 26 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 34 ancestors have a recall of any class.
- 2 other devices also cite its predicate K210885.
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?
Dayspring Lite 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, for the treatment of the following conditions:
• Chronic edema
• Lymphedema
• Venous insufficiency
• Wound healing
Dayspring Lite 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/K212287 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212287: Dayspring Lite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212287
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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