De Novo · Granted
GrantedSnap Wound Care Device
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
Granted on Aug 7, 2009 as a new device type through De Novo after a 277-day review. 18 later devices descend from it.
- Decided
- Aug 7, 2009
- Review
- 277 days
- Class
- Class II
- Product code
- OKO
- Recalls
- None
18 later devices descend from it, 3 citing it directly.
- This deviceDEN080011 Snap Wound Care DeviceSpiracur, Inc. · 2009
- Descendant · cites it directly · 15 of its ownK111393 Snap (R) Wound Care SystemSpiracur, Inc. · 2011
- Descendant · 2 generations on · 14 of its ownK112341 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
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K111393Snap (R) Wound Care SystemSpiracur, Inc. · 2011 · cites it directly15descendants
- K112341Snap Wound Care SystemSpiracur, Inc. · 2011 · 2 generations on14descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN080011 | Snap Wound Care Device | Spiracur, Inc. | 2009 | — |
| +1 | K111393 | Snap (R) Wound Care System | Spiracur, Inc. | 2011 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo database (decision fields), 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (18)
See all 183 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?
- Of its descendants, K111393 (Spiracur, Inc., 2011) has gone furthest, with 15 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. 2009, 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 | — |
https://510kreport.com/device/DEN080011 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN080011: Snap Wound Care Device.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN080011
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026