510(k) · Cleared
ClearedFloSure Ventilation Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simex Medizintechnik GmbH · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Jan 5, 2016 as substantially equivalent to K133333 (Blue Ocean Medical Product, LLC, 2014) after a 316-day review. Its family tree reaches back 7 generations to 1995.
- Decided
- Jan 5, 2016
- Review
- 316 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K945062 (1995). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 6 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 5 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 4 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 3 generations backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- 2 generations backK092992 A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 2010
- 1 generation backK133333 Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT…Blue Ocean Medical Product, LLC · 2014
- This deviceK150459 FloSure Ventilation PatchSimex Medizintechnik GmbH · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −6 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −5 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −4 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −3 | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | 2008 | 1 |
| −2 | K092992 | A4-XLR8 Foam Dressing | Genadyne Biotechnologies, Inc. | 2010 | — |
| −1 | K133333 | Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing… | Blue Ocean Medical Product, LLC | 2014 | — |
| 0 (this device) | K150459 | FloSure Ventilation Patch | Simex Medizintechnik GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K133333 | Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing KitSummary page 4…Class II Device Product Code: OMP - Pump, Portable, Aspiration (manual or powered) Predicate Device: UNI NPWT Foam Wound Dressing Kit (K133333) Indications for Use: The FloSure Ventilation Patch is intended to be used in conjunction with NPWT Dressing Kits compatible wi… | 2014 |
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 6 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K133333.
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. 2016, 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 FloSure Ventilation Patch is intended to be used in conjunction with NPWT Dressing Kits compatible with the SIMEX NPWT Systems EX200 and EX300 for the application of negative pressure wound therapy to the wound. The FloSure Ventilation Patch is to be applied to the occlusive wound dressing. When used in conjunction with the Simex NPWT EX200 and EX300 pumps and dressing kits, the FloSure Ventilation Patch is indicated for patients who would benefit…
Read the full statement (132 words)
The FloSure Ventilation Patch is intended to be used in conjunction with NPWT Dressing Kits compatible with the SIMEX NPWT Systems EX200 and EX300 for the application of negative pressure wound therapy to the wound. The FloSure Ventilation Patch is to be applied to the occlusive wound dressing. When used in conjunction with the Simex NPWT EX200 and EX300 pumps and dressing kits, the FloSure Ventilation Patch is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of wound exudates, infectious material and tissue debris.
The FloSure Ventilation Patch is appropriate for use on the following wounds:
• Pressure Ulcers
• Diabetic/Neuropathic Ulcers
• Venous Insufficiency Ulcers
• Traumatic Wounds
• Post-Operative and Dehisced Surgical Wounds
• Skin Flap and Grafts
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K150459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150459: FloSure Ventilation Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150459
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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