510(k) · Cleared
ClearedVacHeal Negative Pressure Wound Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
VacHeal, LLC · OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Cleared on Sep 18, 2026 as substantially equivalent to K151710 (Spiracur, Inc., 2015) after a 270-day review. Its family tree reaches back 6 generations to 2009.
- Decided
- Sep 18, 2026
- Review
- 270 days
- Class
- Class II
- Product code
- OKO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN080011 (2009). No later device cites it as a predicate yet.
- Root · 6 generations backDEN080011 Snap Wound Care DeviceSpiracur, Inc. · 2009
- 5 generations backK111393 Snap (R) Wound Care SystemSpiracur, Inc. · 2011
- 4 generations backK112341 Snap Wound Care SystemSpiracur, Inc. · 2011
- 3 generations backK132080 Snap Wound Care SystemSpiracur, Inc. · 2014
- 2 generations backK142272 SNaP Wound Care SystemSpiracur, Inc. · 2014
- 1 generation backK151710 SNaP Wound Care SystemSpiracur, Inc. · 2015
- This deviceK254160 VacHeal Negative Pressure Wound Therapy SystemVacHeal, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN080011 | Snap Wound Care Device | Spiracur, Inc. | 2009 | — |
| −5 | K111393 | Snap (R) Wound Care System | Spiracur, Inc. | 2011 | — |
| −4 | K112341 | Snap Wound Care System | Spiracur, Inc. | 2011 | — |
| −3 | K132080 | Snap Wound Care System | Spiracur, Inc. | 2014 | — |
| −2 | K142272 | SNaP Wound Care System | Spiracur, Inc. | 2014 | — |
| −1 | K151710 | SNaP Wound Care System | Spiracur, Inc. | 2015 | — |
| 0 (this device) | K254160 | VacHeal Negative Pressure Wound Therapy System | VacHeal, LLC | 2026 | — |
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 OKO? 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 OKO device
- #1 K250708 NPsealscore 15.1 · 11 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 |
|---|---|---|---|
| * | K151710 | SNaP Wound Care SystemSummary page 5…edicate # Predicate Trade Name Product Code (Primary Predicate is listed first) K151710 SNaP® Wound Care System OKO Device Description The VacHeal™ Negative Pressure Wound Therapy (NPWT)… | 2015 |
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 17 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 6 ancestors has a recall.
- 3 other devices also cite its predicate K151710.
How does its category compare?
All OKO devicesOKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OKO
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OKO
137in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OKO
No recall names OKO since 2007.
Adverse event reports per year · OKO
1in 2023
MAUDE reports naming product code OKO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 4 | 61 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 137 | 0 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The VacHeal™ NPWT System is indicated for patients who would benefit from wound management via application of negative pressure to remove small amounts of exudate from closed surgical incisions.
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/K254160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254160: VacHeal Negative Pressure Wound Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254160
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026