510(k) · Cleared
ClearedCopression Systems (Models CMP-001 and CMP-002)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novitas Medical, LLC · JOW Sleeve, Limb, Compressible
Cleared on Apr 17, 2012 after a 15-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 17, 2012
- Review
- 15 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Compression System is intended to function as an intermittent, sequential pneumatic compression device and each model provides the following specific therapeutic functions: The CMP-OO1 (Compression Plus) is intended for: • Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venious Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema, chronic lymphedema. • Reduction of edema associated with soft…
Read the full statement (259 words)
The Compression System is intended to function as an intermittent, sequential pneumatic compression device and each model provides the following specific therapeutic functions:
The CMP-OO1 (Compression Plus) is intended for:
• Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venious Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema, chronic lymphedema.
• Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains.
• Optional localized thermal therapy (hot or cold) for post traumatic and post surgical, medical and/or surgical conditions
• Aids the blood flow back to the heart
• Treats and assists healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications
The CMP-002 (DVrmax) is intended for:
• Treatment of disorders associated with vascular or lymphatic insufficiency such as Chronic Venous Insufficiency (CVI), venous stasis ulcers, post-mastectomy edema chronic lymphedema
• Reduction of edema associated with soft tissue injuries such as burns, postoperative edema, and ligament sprains
• Optional localized thermal therapy (hot or cold) for post traumatic and post surgical medical and/or surgical conditions
• Decrease the risk of deep venious thrombosis (DVT)
• Aids the blood flow back to the heart,
• Treats and assists healing of cutaneous ulceration (wounds), reduce would healing time, enhance arterial circulation (blood flow), reduce compartmental pressures, reduce edema (swelling), reduce the need for anticoagulant (blood thinning) medications
The device is intended for home or hospital use and the target patient population is adults.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K121001 · printed Nov 4, 2026
Cite this page
510(k) Report. “K121001: Copression Systems (Models CMP-001 and CMP-002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K121001
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026