510(k) · Cleared

Cleared

Snap (R) Wound Care System

K111393510(k) SpecialCleared Jul 28, 201171-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 28, 2011 as substantially equivalent to DEN080011 (Spiracur, Inc., 2009) after a 71-day review. Its family tree reaches back 1 generation to 2009. 15 later devices descend from it.

Decided: Jul 28, 2011
Review: 71 days
Class: Class II
Product code: OKO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to DEN080011 (2009). 15 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backDEN080011 Snap Wound Care DeviceSpiracur, Inc. · 2009
This deviceK111393 Snap (R) Wound Care SystemSpiracur, Inc. · 2011
Descendant · cites it directly · 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
Descendant · 3 generations on · 6 of its ownK200305 NPsealGuard Medical, Inc. · 2020

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2011high 2 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 15 · See all

K112341Snap Wound Care SystemSpiracur, Inc. · 2011 · cites it directly14descendants
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

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)	K111393	Snap (R) Wound Care System	Spiracur, Inc.	2011	—
+1	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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	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

FIG. 1 — Lineage of K111393, 2009–2026Source: 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? (15)

See all 15

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K112341	Snap Wound Care System	Spiracur, Inc.	2011	14
K132080	Snap Wound Care System	Spiracur, Inc.	2014	12
K113032	Snap Wound Care System	Spiracur, Inc.	2011	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, K112341 (Spiracur, Inc., 2011) has gone furthest, with 14 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 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 bums, 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/K111393 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111393: Snap (R) 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/K111393

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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