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 Dec 1, 2011 as substantially equivalent to K111393 (Spiracur, Inc., 2011) and 2 other predicates after a 50-day review. Its family tree reaches back 3 generations to 2009.
- Decided
- Dec 1, 2011
- Review
- 50 days
- Class
- Class II
- Product code
- OKO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to DEN080011 (2009). 4 ancestors in all. No later device cites it as a predicate yet.
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) | K113032 | Snap Wound Care System | Spiracur, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (3)
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 SystemSummary page 2…5 10(k) PREMARKET NOTIFICATION SECTION 5 510(k) SUMMARY PREDICATE DEVICE(S) " Spiracur SNaP® Wound Care System (Ki111393) * Spiracur SNaP® Wound Care System (Ki 12341) * KCI USA, Inc. V.A.C.® Therapy Systems (K091585) DEVICE DESCRIPTION… | 2011 |
| * | K112341 | Snap Wound Care System | 2011 |
| * | K091585 | Vac Therapy System, Models 340000, M8259999, 320000, M8259968 and 320100Summary page 2…EDICATE DEVICE(S) " Spiracur SNaP® Wound Care System (Ki111393) * Spiracur SNaP® Wound Care System (Ki 12341) * KCI USA, Inc. V.A.C.® Therapy Systems (K091585) DEVICE DESCRIPTION The SNaP® Wound Care System ("SNaP? System") is a portable, non-powered suction device intended for wound ma… | 2009 |
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 2 years and passes through 1 company; a new generation was cleared every 3 months on median.
- None of the 4 ancestors has a recall.
- 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113032 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113032: 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/K113032
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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