510(k) · Cleared
Recalled · Class II · 2012Wound Pro Apex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accuro Medical Products, LLC · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Jan 24, 2011 as substantially equivalent to K080357 (Medela AG, 2008) and 1 other predicate after a 306-day review. Its family tree reaches back 4 generations to 1995. 10 later devices descend from it. It has been recalled once.
- Decided
- Jan 24, 2011
- Review
- 306 days
- Class
- Class II
- Product code
- OMP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945062 (1995). 13 ancestors in all, the oldest K933902 (1994). 10 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 3 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 2 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 1 generation backK061367 Bluesky Vista Wound Vacuum System, Model 100.0500Blue Sky Medical Group Incorporated · 2006
- This deviceK100823 Wound Pro ApexAccuro Medical Products, LLC · 2011
- Descendant · cites it directly · 8 of its ownK132225 ExtricareDevon Medical, Inc. · 2014
- Descendant · 2 generations on · 4 of its ownK140634 extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and…Devon Medical, Inc. · 2014
- Descendant · 3 generations on · 3 of its ownK162159 VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK241023 Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK221223 extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K132225ExtricareDevon Medical, Inc. · 2014 · cites it directly8descendants
- K140634extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam…Devon Medical, Inc. · 2014 · 2 generations on4descendants
- K162159VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam DressingVr Medical Technologies, LLC · 2017 · 3 generations on3descendants
- K241023Negative Pressure Wound Therapy Device (V-Move, V-Grand)Med Way, Inc. · 2024 · 2 generations on0descendants
- K221223extriCARE® 3000 Negative Wound Pressure Therapy SystemAlleva Medical Devices · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −3 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −2 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −1 | K061367 | Bluesky Vista Wound Vacuum System, Model 100.0500 | Blue Sky Medical Group Incorporated | 2006 | — |
| 0 (this device) | K100823 | Wound Pro Apex | Accuro Medical Products, LLC | 2011 | — |
| +1 | K132225 | Extricare | Devon Medical, Inc. | 2014 | — |
| +2 | K140634 | extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT… | Devon Medical, Inc. | 2014 | — |
| +3 | K162159 | VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing | Vr Medical Technologies, LLC | 2017 | — |
| +2 | K241023 | Negative Pressure Wound Therapy Device (V-Move, V-Grand) | Med Way, Inc. | 2024 | — |
| +2 | K221223 | extriCARE® 3000 Negative Wound Pressure Therapy System | Alleva Medical Devices | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K080357 | Medela Invia Wound TherapySummary page 1…Classification Name: Negative Pressure Wound Therapy Suction Pump Product Code: OMP (class 2, 21 CFR 878.4780) 3 Name of the Predicate Device(s) Medela Invia - K080357 Blue Sky Vista- K061 367 Page 1 of 7 Rev. 11… | 2008 |
| * | K061367 | Bluesky Vista Wound Vacuum System, Model 100.0500Summary page 1…gative Pressure Wound Therapy Suction Pump Product Code: OMP (class 2, 21 CFR 878.4780) 3 Name of the Predicate Device(s) Medela Invia - K080357 Blue Sky Vista- K061 367 Page 1 of 7 Rev. 11… | 2006 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2012 | Class II | Z-0009-2013 | Device Design | Accuro has received reports of some Apex Pumps either failing to operate or malfunctioning, at times without notifying the user of such failure or malfunction on the unit's display screen. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K132225 (Devon Medical, Inc., 2014) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K080357.
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. 2011, 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 WoundPro Apex Negative Pressure Wound Therapy System may promote wound healing, through the drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts may benefit from the use of this device. The WoundPro Apex is intended for use in a healthcare facility only.
Types of Wounds Indicated are:
Diabetic/Neuropathic ulcers
Pressure ulcers
Chronic wounds
Acute wounds
Dehisced wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100823 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100823: Wound Pro Apex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100823
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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