510(k) · Cleared
ClearedAbthera Open Abdomen Negative Pressure Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kci USA, Inc. (Kinetic Concepts, Inc.) · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Oct 5, 2012 as substantially equivalent to K090489 (Kci USA, Inc., 2009) and 1 other predicate after a 227-day review. Its family tree reaches back 8 generations to 1991.
- Decided
- Oct 5, 2012
- Review
- 227 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K914575 (1991). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- 7 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
- 6 generations backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- 5 generations backK024298 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003
- 4 generations backK050261 V.a.C. Granufoam Silver Protection DressingKinetic Concepts, Inc. · 2005
- 3 generations backK053627 Modification to: V.a.C. Granufoam Silver Protection DressingKci USA, Inc. · 2006
- 2 generations backK062227 V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2006 · Recalled
- 1 generation backK083357 Open Abdomen Negative Pressure Therapy System, Model 370502…Kci USA, Inc. · 2009
- This deviceK120499 Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| −7 | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| −6 | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| −5 | K024298 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2003 | — |
| −4 | K050261 | V.a.C. Granufoam Silver Protection Dressing | Kinetic Concepts, Inc. | 2005 | — |
| −3 | K053627 | Modification to: V.a.C. Granufoam Silver Protection Dressing | Kci USA, Inc. | 2006 | — |
| −2 | K062227 | V.a.C. Therapy System | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2006 | 2 |
| −1 | K083357 | Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model… | Kci USA, Inc. | 2009 | — |
| 0 (this device) | K120499 | Abthera Open Abdomen Negative Pressure Therapy System | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K090489 | Abthera Open Abdomen Dressing, Model: M8275026Summary page 1…ve Pressure Wound Therapy Powered Suction. Pump and Surgical Mesh name~ ,Q~, Dressing Lega IiVmbr-ikeite l, The ABThera Open Abdomen Dressing cleared under K090489 and the ABThera de1V!i(s)to Wfiidl&" Negative Pressure Therapy Unit cleared under K083357. 'Devicd'e dgijn The therapy… | 2009 |
| * | K083357 | Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510Summary page 1…Dressing Lega IiVmbr-ikeite l, The ABThera Open Abdomen Dressing cleared under K090489 and the ABThera de1V!i(s)to Wfiidl&" Negative Pressure Therapy Unit cleared under K083357. 'Devicd'e dgijn The therapy system consists of a therapy unit which delivers negative pressure .~i4A~t… | 2009 |
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 21 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 4 of the 20 ancestors have a recall of any class.
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. 2012, 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 AB Thera Open Abdomen Negative Pressure Therapy System is indicated for temporary bridging of abdominal well openings where primary closure is not possible and/or repeat abdominal entries are necessary. The Intended Use of this system is in open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120499 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120499: Abthera Open Abdomen Negative Pressure Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120499
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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