510(k) · Cleared
ClearedXLR8 Plus (XLR8+)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genadyne Biotechnologies, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Sep 19, 2014 as substantially equivalent to K090638 (Genadyne Biotechnologies, Inc., 2009) after a 112-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Sep 19, 2014
- Review
- 112 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945062 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 4 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 3 generations backK061367 Bluesky Vista Wound Vacuum System, Model 100.0500Blue Sky Medical Group Incorporated · 2006
- 2 generations backK082676 Genadyne A4 Wound Vacuum SystemGenadyne Biotechnologies, Inc. · 2008
- 1 generation backK090638 Genadyne A4-XLR8 Wound Vacuum SystemGenadyne Biotechnologies, Inc. · 2009
- This deviceK141437 XLR8 Plus (XLR8+)Genadyne Biotechnologies, Inc. · 2014
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 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −4 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −3 | K061367 | Bluesky Vista Wound Vacuum System, Model 100.0500 | Blue Sky Medical Group Incorporated | 2006 | — |
| −2 | K082676 | Genadyne A4 Wound Vacuum System | Genadyne Biotechnologies, Inc. | 2008 | — |
| −1 | K090638 | Genadyne A4-XLR8 Wound Vacuum System | Genadyne Biotechnologies, Inc. | 2009 | — |
| 0 (this device) | K141437 | XLR8 Plus (XLR8+) | Genadyne Biotechnologies, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 |
|---|---|---|---|
| * | K090638 | Genadyne A4-XLR8 Wound Vacuum SystemSummary page 4…y 10. Reason for Premarket New Device Notification 11. Identification of Legally A4-XLR8 Wound Vacuum System Marketed Device Which We K090638 Can Claim Substantial Equivalence (Predicate Device) 12. Brief Description of Device The XLR8 Plus (XLR8+)… | 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 19 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
- 1 other device also cites its predicate K090638.
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. 2014, 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 XLR8 Plus (XLR8+) Wound Vacuum System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141437: XLR8 Plus (XLR8+).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141437
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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