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 Aug 29, 2011 as substantially equivalent to K111393 (Spiracur, Inc., 2011) after a 14-day review. Its family tree reaches back 2 generations to 2009. 14 later devices descend from it.
- Decided
- Aug 29, 2011
- Review
- 14 days
- Class
- Class II
- Product code
- OKO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN080011 (2009). 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backDEN080011 Snap Wound Care DeviceSpiracur, Inc. · 2009
- 1 generation backK111393 Snap (R) Wound Care SystemSpiracur, Inc. · 2011
- This deviceK112341 Snap Wound Care SystemSpiracur, Inc. · 2011
- Descendant · cites it directly · 12 of its ownK132080 Snap Wound Care SystemSpiracur, Inc. · 2014
- Descendant · 2 generations on · 11 of its ownK142272 SNaP Wound Care SystemSpiracur, Inc. · 2014
- Descendant · 2 generations on · 10 of its ownK151710 SNaP Wound Care SystemSpiracur, Inc. · 2015
- Descendant · 3 generations on · 6 of its ownK200305 NPsealGuard Medical, Inc. · 2020
- Descendant · 4 generations on · 5 of its ownK211130 NPsealGuard Medical, Inc. · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K132080Snap Wound Care SystemSpiracur, Inc. · 2014 · cites it directly12descendants
- K142272SNaP Wound Care SystemSpiracur, Inc. · 2014 · 2 generations on11descendants
- K151710SNaP Wound Care SystemSpiracur, Inc. · 2015 · 2 generations on10descendants
- K200305NPsealGuard Medical, Inc. · 2020 · 3 generations on6descendants
- K211130NPsealGuard Medical, Inc. · 2021 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN080011 | Snap Wound Care Device | Spiracur, Inc. | 2009 | — |
| −1 | K111393 | Snap (R) Wound Care System | Spiracur, Inc. | 2011 | — |
| 0 (this device) | K112341 | Snap Wound Care System | Spiracur, Inc. | 2011 | — |
| +1 | K132080 | Snap Wound Care System | Spiracur, Inc. | 2014 | — |
| +2 | K142272 | SNaP Wound Care System | Spiracur, Inc. | 2014 | — |
| +2 | K151710 | SNaP Wound Care System | Spiracur, Inc. | 2015 | — |
| +3 | K200305 | NPseal | Guard Medical, Inc. | 2020 | — |
| +4 | K211130 | NPseal | Guard Medical, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 2 | 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? (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 |
|---|---|---|---|
| * | K111393 | Snap (R) Wound Care System | 2011 |
What descends from it? (14)
See all 142 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 2 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K132080 (Spiracur, Inc., 2014) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K111393.
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. 2011, 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 a suction device, particularly as the device may promote wound healing through the removal of excess exudates, 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 or pressure), surgically closed incisions, flaps and grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112341: 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/K112341
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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