510(k) · Cleared
ClearedAbthera Open Abdomen Dressing, Model: M8275026
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kci USA, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on May 14, 2009 as substantially equivalent to K022011 (Kinetic Concepts, Inc., 2003) after a 78-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- May 14, 2009
- Review
- 78 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945062 (1995). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 2 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 1 generation backK022011 V.a.C. Abdominal DressingKinetic Concepts, Inc. · 2003 · Recalled
- This deviceK090489 Abthera Open Abdomen Dressing, Model: M8275026Kci USA, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK120499 Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2012
Most influential descendants
Showing 1 of 1 · See all- K120499Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −2 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −1 | K022011 | V.a.C. Abdominal Dressing | Kinetic Concepts, Inc. | 2003 | 1 |
| 0 (this device) | K090489 | Abthera Open Abdomen Dressing, Model: M8275026 | Kci USA, Inc. | 2009 | — |
| +1 | 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 |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 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 |
|---|---|---|---|
| * | K022011 | V.a.C. Abdominal DressingSummary page 1…Wound Dressing name Classification Class II, CFR 878.3300 Surgical Mesh Legally marketed device(s) to which V.A.C.0 Abdominal Dressing cleared under 510(k) K022011I equivalence is claimed Device description The ABTheraTM Open Abdomen Dressing is a specialty dressin… | 2003 |
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 |
|---|---|---|---|
| K120499 | Abthera Open Abdomen Negative Pressure Therapy System | 2012 | 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 14 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K120499 (Kci USA, Inc. (Kinetic Concepts, Inc.), 2012) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K022011.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The ABThera Open Abdomen Dressing is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary. The Intended Use of this system is for use in open abdominal wounds, with exposed viscera, including but not limited to, abdominal compartment syndrome.
The intended care setting is the acute hospital setting: in trauma, general and plastic surgery wards. 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/K090489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090489: Abthera Open Abdomen Dressing, Model: M8275026.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090489
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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