510(k) · Cleared
ClearedSNaP Wound Care System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spiracur, Inc. · OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus
Cleared on Nov 19, 2015 as substantially equivalent to K142272 (Spiracur, Inc., 2014) and 1 other predicate after a 148-day review. Its family tree reaches back 5 generations to 2009. 10 later devices descend from it.
- Decided
- Nov 19, 2015
- Review
- 148 days
- Class
- Class II
- Product code
- OKO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to DEN080011 (2009). 10 later devices descend from it, 4 citing it directly.
- Root · 5 generations backDEN080011 Snap Wound Care DeviceSpiracur, Inc. · 2009
- 4 generations backK111393 Snap (R) Wound Care SystemSpiracur, Inc. · 2011
- 3 generations backK112341 Snap Wound Care SystemSpiracur, Inc. · 2011
- 2 generations backK132080 Snap Wound Care SystemSpiracur, Inc. · 2014
- 1 generation backK142272 SNaP Wound Care SystemSpiracur, Inc. · 2014
- This deviceK151710 SNaP Wound Care SystemSpiracur, Inc. · 2015
- Descendant · cites it directly · 6 of its ownK200305 NPsealGuard Medical, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK211130 NPsealGuard Medical, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK212971 NPsealGuard Medical, Inc. · 2022
- Descendant · 4 generations on · 3 of its ownK240244 NPseal (Small, Medium, Large)Guard Medical, Inc. · 2024
- Descendant · 5 generations on · 2 of its ownK241522 NPseal (20 and 25)Guard Medical, Inc. · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K200305NPsealGuard Medical, Inc. · 2020 · cites it directly6descendants
- K211130NPsealGuard Medical, Inc. · 2021 · 2 generations on5descendants
- K212971NPsealGuard Medical, Inc. · 2022 · 3 generations on4descendants
- K240244NPseal (Small, Medium, Large)Guard Medical, Inc. · 2024 · 4 generations on3descendants
- K241522NPseal (20 and 25)Guard Medical, Inc. · 2024 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN080011 | Snap Wound Care Device | Spiracur, Inc. | 2009 | — |
| −4 | K111393 | Snap (R) Wound Care System | Spiracur, Inc. | 2011 | — |
| −3 | K112341 | Snap Wound Care System | Spiracur, Inc. | 2011 | — |
| −2 | K132080 | Snap Wound Care System | Spiracur, Inc. | 2014 | — |
| −1 | K142272 | SNaP Wound Care System | Spiracur, Inc. | 2014 | — |
| 0 (this device) | K151710 | SNaP Wound Care System | Spiracur, Inc. | 2015 | — |
| +1 | K200305 | NPseal | Guard Medical, Inc. | 2020 | — |
| +2 | K211130 | NPseal | Guard Medical, Inc. | 2021 | — |
| +3 | K212971 | NPseal | Guard Medical, Inc. | 2022 | — |
| +4 | K240244 | NPseal (Small, Medium, Large) | Guard Medical, Inc. | 2024 | — |
| +5 | K241522 | NPseal (20 and 25) | Guard Medical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K142272 | SNaP Wound Care SystemSummary page 5…Page 1 of 5 510(k) SUMMARY III. PREDICATE DEVICES [807.92(a)(3)] Spiracur Inc. SNaP® Wound Care Systems (K142272 and K132080) are cited as predicate devices for this premarket notification. In addition, to support change… | 2014 |
| * | K132080 | Snap Wound Care SystemSummary page 5…Page 1 of 5 510(k) SUMMARY III. PREDICATE DEVICES [807.92(a)(3)] Spiracur Inc. SNaP® Wound Care Systems (K142272 and K132080) are cited as predicate devices for this premarket notification. In addition, to support changes that are t… | 2014 |
| † | K120033 | Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom… | 2012 |
| † | K133137 | Cisnap Closed Incision System | 2014 |
What descends from it? (10)
4 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)
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 6 years and passes through 1 company; a new generation was cleared every 12 months on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K200305 (Guard Medical, Inc., 2020) has gone furthest, with 6 descendants of its own.
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. 2015, 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 SNaP® Wound Care System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The SNaP® Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as…
Read the full statement (151 words)
The SNaP® Wound Care System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The SNaP® Wound Care System is indicated for removal of small amounts of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps and grafts.
The SNaP® Wound Care System is indicated for patients who would benefit from wound management via the application of negative pressure, particularly as the device may promote wound healing through the removal of excess exudate, infectious material and tissue debris. The SNaP® Wound Care System is indicated for removal of exudate from chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps and grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151710: SNaP Wound Care System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151710
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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