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 Mar 12, 2014 as substantially equivalent to DEN080011 (Spiracur, Inc., 2009) and 2 other predicates after a 250-day review. Its family tree reaches back 3 generations to 2009. 12 later devices descend from it.
- Decided
- Mar 12, 2014
- Review
- 250 days
- Class
- Class II
- Product code
- OKO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to DEN080011 (2009). 12 later devices descend from it, 2 citing it directly.
- Root · 3 generations backDEN080011 Snap Wound Care DeviceSpiracur, Inc. · 2009
- 2 generations backK111393 Snap (R) Wound Care SystemSpiracur, Inc. · 2011
- 1 generation backK112341 Snap Wound Care SystemSpiracur, Inc. · 2011
- This deviceK132080 Snap Wound Care SystemSpiracur, Inc. · 2014
- Descendant · cites it directly · 11 of its ownK142272 SNaP Wound Care SystemSpiracur, Inc. · 2014
- Descendant · cites it directly · 10 of its ownK151710 SNaP Wound Care SystemSpiracur, Inc. · 2015
- Descendant · 2 generations on · 6 of its ownK200305 NPsealGuard Medical, Inc. · 2020
- Descendant · 3 generations on · 5 of its ownK211130 NPsealGuard Medical, Inc. · 2021
- Descendant · 4 generations on · 4 of its ownK212971 NPsealGuard Medical, Inc. · 2022
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K142272SNaP Wound Care SystemSpiracur, Inc. · 2014 · cites it directly11descendants
- K151710SNaP Wound Care SystemSpiracur, Inc. · 2015 · cites it directly10descendants
- K200305NPsealGuard Medical, Inc. · 2020 · 2 generations on6descendants
- K211130NPsealGuard Medical, Inc. · 2021 · 3 generations on5descendants
- K212971NPsealGuard Medical, Inc. · 2022 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN080011 | Snap Wound Care Device | Spiracur, Inc. | 2009 | — |
| −2 | K111393 | Snap (R) Wound Care System | Spiracur, Inc. | 2011 | — |
| −1 | K112341 | Snap Wound Care System | Spiracur, Inc. | 2011 | — |
| 0 (this device) | K132080 | Snap Wound Care System | Spiracur, Inc. | 2014 | — |
| +1 | K142272 | SNaP Wound Care System | Spiracur, Inc. | 2014 | — |
| +1 | K151710 | SNaP Wound Care System | Spiracur, Inc. | 2015 | — |
| +2 | K200305 | NPseal | Guard Medical, Inc. | 2020 | — |
| +3 | K211130 | NPseal | Guard Medical, Inc. | 2021 | — |
| +4 | K212971 | NPseal | Guard Medical, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN080011 | Snap Wound Care Device Our reading of the summary gave K081406, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN080011, Snap Wound Care Device (Spiracur, Inc.), granted Aug 7, 2009; older De Novo requests were first filed under a 510(k) number, so this links to the grant. | 2009 |
| * | K111393 | Snap (R) Wound Care SystemSummary page 3…to assess the ability of the SNaP Wound Care System to deliver negative pressure wound therapy comparable to the predicate device (K081406, KI 111393, KI 1234 1, KI 113032) when used in conjunction with the SNaP Bridge Dressing Kit and the SNaP SecurRin… | 2011 |
| * | K112341 | Snap Wound Care System | 2011 |
| Kept off the family tree | K130032 | SNaP Wound Care System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (12)
See all 122 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 5 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K142272 (Spiracur, Inc., 2014) has gone furthest, with 11 descendants of its own.
- 2 other devices also cite its predicate DEN080011.
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. 2014, 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 bums, 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/K132080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132080: 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/K132080
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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