510(k) · Cleared
ClearedNPseal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guard Medical, Inc. · OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Cleared on May 15, 2025 as substantially equivalent to K250708 (Guard Medical, Inc., 2025) after a 30-day review. Its family tree reaches back 12 generations to 2009.
- Decided
- May 15, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- OKO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to DEN080011 (2009). No later device cites it as a predicate yet.
- Root · 12 generations backDEN080011 Snap Wound Care DeviceSpiracur, Inc. · 2009
- 8 generations between
- 3 generations backK240244 NPseal (Small, Medium, Large)Guard Medical, Inc. · 2024
- 2 generations backK241522 NPseal (20 and 25)Guard Medical, Inc. · 2024
- 1 generation backK250708 NPsealGuard Medical, Inc. · 2025
- This deviceK251156 NPsealGuard Medical, Inc. · 2025
Show all 12 generations
- Root · 12 generations backDEN080011 Snap Wound Care DeviceSpiracur, Inc. · 2009
- 11 generations backK111393 Snap (R) Wound Care SystemSpiracur, Inc. · 2011
- 10 generations backK112341 Snap Wound Care SystemSpiracur, Inc. · 2011
- 9 generations backK132080 Snap Wound Care SystemSpiracur, Inc. · 2014
- 8 generations backK142272 SNaP Wound Care SystemSpiracur, Inc. · 2014
- 7 generations backK151710 SNaP Wound Care SystemSpiracur, Inc. · 2015
- 6 generations backK200305 NPsealGuard Medical, Inc. · 2020
- 5 generations backK211130 NPsealGuard Medical, Inc. · 2021
- 4 generations backK212971 NPsealGuard Medical, Inc. · 2022
- 3 generations backK240244 NPseal (Small, Medium, Large)Guard Medical, Inc. · 2024
- 2 generations backK241522 NPseal (20 and 25)Guard Medical, Inc. · 2024
- 1 generation backK250708 NPsealGuard Medical, Inc. · 2025
- This deviceK251156 NPsealGuard Medical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | DEN080011 | Snap Wound Care Device | Spiracur, Inc. | 2009 | — |
| −11 | K111393 | Snap (R) Wound Care System | Spiracur, Inc. | 2011 | — |
| −10 | K112341 | Snap Wound Care System | Spiracur, Inc. | 2011 | — |
| −9 | K132080 | Snap Wound Care System | Spiracur, Inc. | 2014 | — |
| −8 | K142272 | SNaP Wound Care System | Spiracur, Inc. | 2014 | — |
| −7 | K151710 | SNaP Wound Care System | Spiracur, Inc. | 2015 | — |
| −6 | K200305 | NPseal | Guard Medical, Inc. | 2020 | — |
| −5 | K211130 | NPseal | Guard Medical, Inc. | 2021 | — |
| −4 | K212971 | NPseal | Guard Medical, Inc. | 2022 | — |
| −3 | K240244 | NPseal (Small, Medium, Large) | Guard Medical, Inc. | 2024 | — |
| −2 | K241522 | NPseal (20 and 25) | Guard Medical, Inc. | 2024 | — |
| −1 | K250708 | NPseal | Guard Medical, Inc. | 2025 | — |
| 0 (this device) | K251156 | NPseal | Guard Medical, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K250708 | NPsealSummary page 5…Classification: Class II Product Code: OKO (21 CFR 878.4683) Predicate Device: NPseal (K250708) 4. Device Description The NPseal Negative Pressure Advanced System is a single-use device that includes an… | 2025 |
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 16 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- None of the 12 ancestors has a recall.
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. 2025, 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 NPseal is indicated for patients who would benefit from wound management via application of negative pressure, particularly as the device may promote wound healing through the removal of small amounts of exudates from closed surgical incisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251156 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251156: NPseal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251156
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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