510(k) · Cleared
ClearedCurasys 2 (EMDN0003)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CG Bio Co., Ltd. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Jun 23, 2026 as substantially equivalent to K201571 (Kci USA, Inc., 2020) after a 270-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jun 23, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945062 (1995). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 4 generations backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
- 3 generations backK063692 V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc. · 2007 · Recalled
- 2 generations backK183543 ACTIV.A.C. Therapy UnitKci USA, Inc. · 2019 · Recalled
- 1 generation backK201571 ACTIV.A.C. Negative Pressure Wound Therapy SystemKci USA, Inc. · 2020
- This deviceK253199 Curasys 2 (EMDN0003)CG Bio Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −5 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −4 | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. Ats | Kinetic Concepts, Inc. | 2003 | 2 |
| −3 | K063692 | V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000 | Kci USA, Inc. | 2007 | 1 |
| −2 | K183543 | ACTIV.A.C. Therapy Unit | Kci USA, Inc. | 2019 | 1 |
| −1 | K201571 | ACTIV.A.C. Negative Pressure Wound Therapy System | Kci USA, Inc. | 2020 | — |
| 0 (this device) | K253199 | Curasys 2 (EMDN0003) | CG Bio Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 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 OMP? 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 OMP device
- #1 K260646 Renasys Edge (66803126)score 15.3 · 14 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 |
|---|---|---|---|
| * | K201571 | ACTIV.A.C. Negative Pressure Wound Therapy SystemSummary page 5…tion Name: Powered suction pump Regulation Number: 21 CFR 878.4780 Product Code: OMP Device Class: Class II 3. Predicate Device Information ACTIV.A.C.™ NPWT System, K201571 KCI / 3M 4. Device Description The CURASYS 2 Negative Pressure Wound Therapy (NPWT) System is a portable, software- controlle… | 2020 |
| † | K122490 | Kulavac | 2013 |
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 31 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- 4 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K201571.
How does its category compare?
All OMP devicesOMP Negative Pressure Wound Therapy Powered Suction Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OMP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMP
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMP
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMP
140in 2025
MAUDE reports naming product code OMP, 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 | 113 | 0 | 1 |
| 2008 | 8 | 98 | 0 | 1 |
| 2009 | 8 | 87 | 7 | 79 |
| 2010 | 6 | 97 | 3 | 80 |
| 2011 | 6 | 123 | 0 | 130 |
| 2012 | 11 | 292 | 1 | 97 |
| 2013 | 11 | 84 | 2 | 169 |
| 2014 | 10 | 179 | 4 | 229 |
| 2015 | 20 | 189 | 1 | 378 |
| 2016 | 19 | 146 | 2 | 398 |
| 2017 | 11 | 137 | 0 | 368 |
| 2018 | 13 | 214 | 0 | 422 |
| 2019 | 15 | 249 | 1 | 994 |
| 2020 | 6 | 179 | 0 | 3,664 |
| 2021 | 9 | 238 | 0 | 1,422 |
| 2022 | 10 | 229 | 0 | 258 |
| 2023 | 8 | 291 | 0 | 143 |
| 2024 | 9 | 181 | 2 | 135 |
| 2025 | 5 | 127 | 0 | 140 |
| 2026 | 9 | 141 | 0 | — |
What is it indicated for?
The CURASYS 2 Negative Pressure Wound Therapy (NPWT) System is an integrated wound management system for use in acute and extended care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open…
Read the full statement (133 words)
The CURASYS 2 Negative Pressure Wound Therapy (NPWT) System is an integrated wound management system for
use in acute and extended care settings.
When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary
(delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue
formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute,
traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous
insufficiency), flaps and grafts.
When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to
drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application
of negative pressure wound therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253199: Curasys 2 (EMDN0003).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253199
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026