510(k) · Cleared

Cleared

CI-Snap Wound Care System

K111006510(k) TraditionalCleared Jul 21, 2011101-day reviewClass II21 CFR 878.4683

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spiracur, Inc. · OKO Negative Pressure Wound Therapy Non-Powered Suction Apparatus

Cleared on Jul 21, 2011 as substantially equivalent to DEN080011 (Spiracur, Inc., 2009) after a 101-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.

Decided: Jul 21, 2011
Review: 101 days
Class: Class II
Product code: OKO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN080011 (2009). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backDEN080011 Snap Wound Care DeviceSpiracur, Inc. · 2009
This deviceK111006 CI-Snap Wound Care SystemSpiracur, Inc. · 2011
Descendant · cites it directly · 0 of its ownK133137 Cisnap Closed Incision SystemSpiracur, Inc. · 2014

Most influential descendants

Showing 1 of 1 · See all

K133137Cisnap Closed Incision SystemSpiracur, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	DEN080011	Snap Wound Care Device	Spiracur, Inc.	2009	—
0 (this device)	K111006	CI-Snap Wound Care System	Spiracur, Inc.	2011	—
+1	K133137	Cisnap Closed Incision System	Spiracur, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K111006, 2009–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	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.	Spiracur, Inc.	2009	—

Also cleared against DEN080011: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K133137	Cisnap Closed Incision System	Spiracur, Inc.	2014	0

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?

Its one ancestor has no recall.
Of its descendants, K133137 (Spiracur, Inc., 2014) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate DEN080011.

How does its category compare?

All OKO devices

OKO 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

2007high 4 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OKO

137in 2014

2007high 137 (2014) · low 61 (2011)2026

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

2007high 2 (2018) · low 0 (2007)2025

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	1
2011	4	61	0
2012	0	—	0
2013	0	—	0
2014	3	137	1
2015	1	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	2
2019	0	—	2
2020	2	—	0
2021	1	—	1
2022	1	—	0
2023	0	—	1
2024	2	—	0
2025	2	—	0
2026	1	—	—

What is it indicated for?

The Cl-SNaPTM 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 small amounts of exudates 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/K111006 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111006: CI-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/K111006

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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