510(k) · Cleared

Cleared

Woundclot Hemostatic Gauze

K140573510(k) TraditionalCleared Nov 24, 2014263-day reviewClass U

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

Core Scientific, Ltd. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

Cleared on Nov 24, 2014 as substantially equivalent to K080532 (Unicare Biomedical, Inc., 2008) after a 263-day review. Its family tree reaches back 1 generation to 2008. 1 later device descends from it.

Decided: Nov 24, 2014
Review: 263 days
Class: Class U
Product code: QSY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K080532 (2008). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK080532 Benacel, Models C-001, C-002 and C-005Unicare Biomedical, Inc. · 2008
This deviceK140573 Woundclot Hemostatic GauzeCore Scientific, Ltd. · 2014
Descendant · cites it directly · 0 of its ownK160679 WoundClot9Core Scientific Creation, Ltd. · 2016

Most influential descendants

Showing 1 of 1 · See all

K160679WoundClot9Core Scientific Creation, Ltd. · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K080532	Benacel, Models C-001, C-002 and C-005	Unicare Biomedical, Inc.	2008	—
0 (this device)	K140573	Woundclot Hemostatic Gauze	Core Scientific, Ltd.	2014	—
+1	K160679	WoundClot9	Core Scientific Creation, Ltd.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K140573, 2008–2016Source: 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

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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
*	K080532	Benacel, Models C-001, C-002 and C-005 Summary page 5 …static Gauze Classification Name: Dressing, Wound, Drug Regulatory Class: Unclassified Medical Device Product Code: FRO III. PREDICATE DEVICE BenaCel Hemostatic Gauze, K080532 This predicate has not been subject to a design-related recall. No reference devices were used in this submission. === Page 6 =…	Unicare Biomedical, Inc.	2008	—

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
K160679	WoundClot9	Core Scientific Creation, Ltd.	2016	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, K160679 (Core Scientific Creation, Ltd., 2016) has gone furthest, with 0 descendants of its own.

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. 2014, 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?

WoundClot Hemostatic Gauze is intended to be used as a topical dressing for local management of bleeding wounds, such as cuts, lacerations and abrasions, and for use as a temporary treatment of severely bleeding wounds, such as surgical wounds (operative, postoperative, donor sites, dermatological) and traumatic injuries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140573 · printed Nov 4, 2026

Cite this page

510(k) Report. “K140573: Woundclot Hemostatic Gauze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K140573

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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