510(k) · Cleared
ClearedElastiMed SACS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elastimed, Ltd. · JOW Sleeve, Limb, Compressible
Cleared on Dec 22, 2023 as substantially equivalent to K162481 (Recovery Force, LLC, 2017) after a 143-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.
- Decided
- Dec 22, 2023
- Review
- 143 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K944567 (1995). 14 ancestors in all, the oldest K915092 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
- 6 generations backK981311 Cowboy XVKci New Technologies, Inc. · 1999
- 5 generations backK993758 Proair 3000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
- 4 generations backK060146 Activecare ++ SystemMedical Compression Systems (Dbn), Ltd. · 2006 · Recalled
- 3 generations backK110159 Activecare SFTMedical Compression Systems (Dbn), Ltd. · 2011
- 2 generations backK140755 Activecare DVT, Activecare+SFT, and Activecare+DTX SystemsMedical Compression Systems (Dbn), Ltd. · 2014
- 1 generation backK162481 RF1400 Active Compression WrapRecovery Force, LLC · 2017
- This deviceK232300 ElastiMed SACSElastimed, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK243177 Sacs ProElastimed, Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K243177Sacs ProElastimed, Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K944567 | Cowboy X | Kinetic Concepts, Inc. | 1995 | 1 |
| −6 | K981311 | Cowboy XV | Kci New Technologies, Inc. | 1999 | — |
| −5 | K993758 | Proair 3000 Compression System | Medical Compression Systems (Dbn), Ltd. | 2000 | — |
| −4 | K060146 | Activecare ++ System | Medical Compression Systems (Dbn), Ltd. | 2006 | 1 |
| −3 | K110159 | Activecare SFT | Medical Compression Systems (Dbn), Ltd. | 2011 | — |
| −2 | K140755 | Activecare DVT, Activecare+SFT, and Activecare+DTX Systems | Medical Compression Systems (Dbn), Ltd. | 2014 | — |
| −1 | K162481 | RF1400 Active Compression Wrap | Recovery Force, LLC | 2017 | — |
| 0 (this device) | K232300 | ElastiMed SACS | Elastimed, Ltd. | 2023 | — |
| +1 | K243177 | Sacs Pro | Elastimed, Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K162481 | RF1400 Active Compression WrapSummary page 4…Compressible Regulatory Class: II Product Code: JOW C.F.R. Section no.: 21 C.F.R. § 870.5800 Predicate Device: Recovery Force LLC., RF1400 Active Compression Wrap (K162481) Reference Device: Tactile Systems Technology Inc., ActiTouch ACT-Adaptive Compression Therapy System (K131193) Device Descrip… | 2017 |
| † | K131193 | Actitouch Act-Adaptive Compression Therapy System | 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 |
|---|---|---|---|
| K243177 | Sacs Pro | 2024 | 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 28 years and passes through 5 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K243177 (Elastimed, Ltd., 2024) has gone furthest, with 0 descendants 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. 2023, 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 ElastiMed’s SACS device is a portable and lightweight device intended to provide compression in both sustained and intermittent settings by stimulating blood flow in the legs. The SACS device is intended for: - Aid in the prevention of DVT. - Enhance blood circulation. - Diminish post-operative pain and swelling. - Reduce wound healing time. - Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg…
Read the full statement (133 words)
The ElastiMed’s SACS device is a portable and lightweight device intended to provide compression in both sustained and
intermittent settings by stimulating blood flow in the legs. The SACS device is intended for:
- Aid in the prevention of DVT.
- Enhance blood circulation.
- Diminish post-operative pain and swelling.
- Reduce wound healing time.
- Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic
venous insufficiency, chronic lymphedema, and reduction of edema in the lower limbs.
- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time.
- Reduction of edema associated with soft tissue injuries, such as burns, postoperative or post-immobilization edema,
or ligament sprains.
The device can be used in the home or clinical setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232300: ElastiMed SACS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232300
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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