510(k) · Cleared
ClearedCisnap Closed Incision 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 Feb 25, 2014 as substantially equivalent to K111006 (Spiracur, Inc., 2011) and 3 other predicates after a 137-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Feb 25, 2014
- Review
- 137 days
- Class
- Class II
- Product code
- OKO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K914579 (1992). 9 ancestors in all, the oldest K890354 (1989). No later device cites it as a predicate yet.
- Root · 4 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 3 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 2 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 1 generation backK040518 Select Fabricators, Inc., Agmed Tex Wound DressingSelect Fabricators, Inc. · 2004
- This deviceK133137 Cisnap Closed Incision SystemSpiracur, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −3 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −2 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −1 | K040518 | Select Fabricators, Inc., Agmed Tex Wound Dressing | Select Fabricators, Inc. | 2004 | — |
| 0 (this device) | K133137 | Cisnap Closed Incision System | Spiracur, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111006 | CI-Snap Wound Care SystemSummary page 4…ed use. SUMMARY The ciSNaP System has the same intended use and technological characteristics as the predicate devices: the existing Spiracur Cl-SNaP Wound Care System (K111006) and the KCI Prevena' M Incision Management System (K 10082 1). The ciSNaP Controlled Tension Relief Layer has a similar intended… | 2011 |
| * | K100821 | Prevena Incision Management SystemSummary page 2…== 510(k) SuNINIARY (CONT.) PREDICATE DEVICE(S) * Spiracur Inc. Cl-SNaP Wound Care System (KI 11006) * KCI USA, Inc. Prevena' M Incision Management System (K100821) " Argentum International, LLC Silverlon' Contact Wound Dressing (K98 1299) " Select Fabricators, Inc. Ag MedTex Woun… | 2010 |
| * | K981299 | Silverlon Contact Wound DressingSummary page 2…Wound Care System (KI 11006) * KCI USA, Inc. Prevena' M Incision Management System (K100821) " Argentum International, LLC Silverlon' Contact Wound Dressing (K98 1299) " Select Fabricators, Inc. Ag MedTex Wound Dressing (K0405 18) INTENDED USE The ciSNaP0 Closed Incision System is indicat… | 1998 |
| * | K040518 | Select Fabricators, Inc., Agmed Tex Wound DressingSummary page 2…n Management System (K100821) " Argentum International, LLC Silverlon' Contact Wound Dressing (K98 1299) " Select Fabricators, Inc. Ag MedTex Wound Dressing (K0405 18) INTENDED USE The ciSNaP0 Closed Incision System is indicated for patients who would benefit from wound management via the appli… | 2004 |
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 22 years and passes through 5 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 9 ancestors has a recall of any class.
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 ciSNaP® Closed Incision 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 small amounts of exudate from
surgical incisions that continue to drain following sutured or stapled closure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133137: Cisnap Closed Incision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133137
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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