510(k) · Cleared

Cleared

Chito-Seal

K021062510(k) TraditionalCleared Aug 23, 2002143-day reviewClass U

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

Abbott Vascular, Inc. · QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

Cleared on Aug 23, 2002 as substantially equivalent to K984177 (Marine Polymer Technologies, Inc., 1998) after a 143-day review. Its family tree reaches back 1 generation to 1998. 48 later devices descend from it.

Decided: Aug 23, 2002
Review: 143 days
Class: Class U
Product code: QSY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K984177 (1998). 48 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK984177 Modification to SkvekpatchMarine Polymer Technologies, Inc. · 1998
This deviceK021062 Chito-SealAbbott Vascular, Inc. · 2002
Descendant · cites it directly · 25 of its ownK032986 Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004
Descendant · cites it directly · 14 of its ownK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
Descendant · cites it directly · 14 of its ownK040208 Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandTz Medical, Inc. · 2004 · Recalled
Descendant · 2 generations on · 13 of its ownK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
Descendant · cites it directly · 11 of its ownK080818 Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008

Showing 5 of 48 descendants. See all descendants

Descendants cleared per year

2004high 6 (2015) · low 0 (2005)2026

Most influential descendants

Showing 5 of 48 · See all

K032986Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc. · 2004 · cites it directly25descendants
K053300SyvekexcelMarine Polymer Technologies, Inc. · 2006 · cites it directly14descendants
K040208Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandTz Medical, Inc. · 2004 · cites it directly14descendants
K061219D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006 · 2 generations on13descendants
K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc. · 2008 · cites it directly11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K984177	Modification to Skvekpatch	Marine Polymer Technologies, Inc.	1998	—
0 (this device)	K021062	Chito-Seal	Abbott Vascular, Inc.	2002	—
+1	K032986	Clo-Surplusp.a.D.	Scion Cardio-Vascular, Inc.	2004	—
+1	K053300	Syvekexcel	Marine Polymer Technologies, Inc.	2006	—
+1	K040208	Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band	Tz Medical, Inc.	2004	1
+2	K061219	D-Stat Dry Hemostatic Bandage	Vascular Solutions, Inc.	2006	—
+1	K080818	Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing	Hem Con Medical Technologies, Inc.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2006	2	0
2007	2	0
2008	1	0
2009	4	0
2010	4	0
2011	3	0
2012	1	0
2013	2	0
2014	2	0
2015	6	0
2016	3	0
2017	3	0
2018	3	0
2019	3	0
2021	1	0
2022	2	0
2023	2	0
2024	1	0
2026	1	0

FIG. 1 — Lineage of K021062, 1998–2026Source: 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 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
*	K984177	Modification to Skvekpatch Summary page 5 …G. Classification Name: Dressing H. Product Code: 79FRO I. Predicate Device: Marine Polymer TechnoloDes SyvekPatch@(K984177) J. Intended Use: Chito-Seal is indicated for use in the management of bleeding wounds such as vascular…	Marine Polymer Technologies, Inc.	1998	—

Also cleared against K984177: 9 other devices →

What descends from it? (48)

See all 48

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

Number	Device	Applicant	Decided	Descendants
K032986	Clo-Surplusp.a.D.	Scion Cardio-Vascular, Inc.	2004	25
K053300	Syvekexcel	Marine Polymer Technologies, Inc.	2006	14
K040208	Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-Band	Tz Medical, Inc.	2004	14
K080818	Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical Dressing	Hem Con Medical Technologies, Inc.	2008	11
K102944	Coreleader Hemo-Pad Model Cpii 02030	Coreleader Biotech Co., Ltd.	2011	2

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, K032986 (Scion Cardio-Vascular, Inc., 2004) has gone furthest, with 25 descendants of its own.
9 other devices also cite its predicate K984177.

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.

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?

Chito-Seal is indicated for use in the management of bleeding wounds such as vascular access sites and percutaneous catheters or tubes. Chito-Seal promotes the rapid control of bleeding in patients on hemodialysis and in patients on anticoagulation therapy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021062 · printed Nov 5, 2026

Cite this page

510(k) Report. “K021062: Chito-Seal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021062

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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