510(k) · Cleared

Cleared

Clo-Surplus P.a.D.

K112961510(k) SpecialCleared Oct 31, 201127-day reviewClass U

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

Scion Cardio-Vascular, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

Cleared on Oct 31, 2011 as substantially equivalent to K092552 (Scion Cardio-Vascular, Inc., 2009) after a 27-day review. Its family tree reaches back 1 generation to 2009. 4 later devices descend from it.

Decided: Oct 31, 2011
Review: 27 days
Class: Class U
Product code: QSY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K092552 (2009). 4 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK092552 Clo-Surplus P.a.D.Scion Cardio-Vascular, Inc. · 2009
This deviceK112961 Clo-Surplus P.a.D.Scion Cardio-Vascular, Inc. · 2011
Descendant · cites it directly · 3 of its ownK150916 HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip…Hem Con Medical Technologies, Inc. · 2015
Descendant · 2 generations on · 1 of its ownK182811 gel-e Flex+Gel-E, Inc. · 2019
Descendant · 2 generations on · 0 of its ownK202830 Axiostat PatchAdvamedica, Inc. · 2021
Descendant · 3 generations on · 0 of its ownK192667 gel-e Flex+ gel OTCGel-E, Inc. · 2019

Most influential descendants

Showing 4 of 4 · See all

K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc. · 2015 · cites it directly3descendants
K182811gel-e Flex+Gel-E, Inc. · 2019 · 2 generations on1descendant
K202830Axiostat PatchAdvamedica, Inc. · 2021 · 2 generations on0descendants
K192667gel-e Flex+ gel OTCGel-E, Inc. · 2019 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K092552	Clo-Surplus P.a.D.	Scion Cardio-Vascular, Inc.	2009	—
0 (this device)	K112961	Clo-Surplus P.a.D.	Scion Cardio-Vascular, Inc.	2011	—
+1	K150916	HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid…	Hem Con Medical Technologies, Inc.	2015	—
+2	K182811	gel-e Flex+	Gel-E, Inc.	2019	—
+2	K202830	Axiostat Patch	Advamedica, Inc.	2021	—
+3	K192667	gel-e Flex+ gel OTC	Gel-E, Inc.	2019	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	1	0
2019	2	0
2021	1	0

FIG. 1 — Lineage of K112961, 2009–2021Source: 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 QSY? 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 QSY device

#1 K240713 Traumagel®score 15.0 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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
*	K092552	Clo-Surplus P.a.D. Summary page 5 …) 259-8880 Ext 103 Fax: (305)259-8878 September 14, 2011 Clo-Sur™s pAD™ Topical Hemostasis Pad Unclassified Topical Wound Dressing Pad Scion Cardio-Vascular, Inc, K092552, CLO-SUR™S P AD,, The Scion Cardio-Vascular Clo-Sur™5 PAD™ is a soft, non- woven topical pad that provides an optimal wound heal…	Scion Cardio-Vascular, Inc.	2009	—

Also cleared against K092552: 2 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K150916	HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…	Hem Con Medical Technologies, Inc.	2015	3

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, K150916 (Hem Con Medical Technologies, Inc., 2015) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K092552.

How does its category compare?

All QSY devices

QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · QSY

2in 2025

2007high 13 (2007) · low 1 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QSY

142in 2024

2007high 586 (2023) · low 55 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · QSY

No recall names QSY since 2007.

Adverse event reports per year · QSY

14in 2025

2007high 14 (2025) · low 0 (2007)2025

MAUDE reports naming product code QSY, 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	13	63	0
2008	7	61	0
2009	9	55	0
2010	7	75	0
2011	8	137	0
2012	7	239	0
2013	3	161	0
2014	6	249	0
2015	6	171	0
2016	5	161	0
2017	1	—	0
2018	5	186	0
2019	4	336	0
2020	1	—	0
2021	1	—	0
2022	2	—	1
2023	7	586	0
2024	4	142	3
2025	2	—	14
2026	2	—	—

What is it indicated for?

The Scion Cardio-Vascular Clo-Sur™S P.A.D. is intended for the local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy.

The dressing is indicated for the following wounds: lacerations, abrasions, nose bleeds, surgical debridement sites, skin surface puncture sites, vascular procedure sites, and sites involving percutaneous catheters, tubes and pins.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K112961 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112961: Clo-Surplus P.a.D..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112961

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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