510(k) · Cleared

Cleared

Syvek Patch

K972914510(k) TraditionalCleared Dec 22, 1997137-day reviewClass I21 CFR 880.5240

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

Marine Polymer Technologies, Inc. · KGX Tape And Bandage, Adhesive

Cleared on Dec 22, 1997 after a 137-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 99 later devices descend from it.

Decided: Dec 22, 1997
Review: 137 days
Class: Class I
Product code: KGX
Recalls: None
Predicates: 0

99 later devices descend from it, 2 citing it directly.

This deviceK972914 Syvek PatchMarine Polymer Technologies, Inc. · 1997
Descendant · cites it directly · 74 of its ownK023298 Hemcon BandageHemcon, Inc. · 2002
Descendant · 2 generations on · 56 of its ownK030946 Hemcon Bandage Otc; Hemcon Cath/AidHemcon, Inc. · 2003
Descendant · 2 generations on · 55 of its ownK043050 Hemcon Bandage and Hemcon Bandage OtcHemcon, Inc. · 2005
Descendant · cites it directly · 44 of its ownK030334 T-Scientific T-PadT-Scientific, Inc. · 2003
Descendant · 3 generations on · 35 of its ownK072486 Modification to Hemcon Bandage and Hemcon Bandage OtcHem Con Medical Technologies, Inc. · 2008 · Recalled

Showing 5 of 99 descendants. See all descendants

Descendants cleared per year

2002high 9 (2023) · low 1 (2002)2026

Most influential descendants

Showing 5 of 99 · See all

K023298Hemcon BandageHemcon, Inc. · 2002 · cites it directly74descendants
K030946Hemcon Bandage Otc; Hemcon Cath/AidHemcon, Inc. · 2003 · 2 generations on56descendants
K043050Hemcon Bandage and Hemcon Bandage OtcHemcon, Inc. · 2005 · 2 generations on55descendants
K030334T-Scientific T-PadT-Scientific, Inc. · 2003 · cites it directly44descendants
K072486Modification to Hemcon Bandage and Hemcon Bandage OtcHem Con Medical Technologies, Inc. · 2008 · 3 generations on35descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K972914	Syvek Patch	Marine Polymer Technologies, Inc.	1997	—
+1	K023298	Hemcon Bandage	Hemcon, Inc.	2002	—
+2	K030946	Hemcon Bandage Otc; Hemcon Cath/Aid	Hemcon, Inc.	2003	—
+2	K043050	Hemcon Bandage and Hemcon Bandage Otc	Hemcon, Inc.	2005	—
+1	K030334	T-Scientific T-Pad	T-Scientific, Inc.	2003	—
+3	K072486	Modification to Hemcon Bandage and Hemcon Bandage Otc	Hem Con Medical Technologies, Inc.	2008	6

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	3	0
2004	1	0
2005	1	0
2006	2	0
2007	6	0
2008	5	0
2009	6	0
2010	6	0
2011	4	0
2012	4	0
2013	4	0
2014	6	0
2015	6	0
2016	4	0
2017	3	0
2018	6	0
2019	5	0
2020	1	0
2021	1	0
2022	4	0
2023	9	0
2024	6	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K972914, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KGX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (99)

See all 99

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

Number	Device	Applicant	Decided	Descendants
K023298	Hemcon Bandage	Hemcon, Inc.	2002	74
K030334	T-Scientific T-Pad	T-Scientific, Inc.	2003	44

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?

Of its descendants, K023298 (Hemcon, Inc., 2002) has gone furthest, with 74 descendants of its own.

How does its category compare?

All KGX devices

KGX Tape And Bandage, Adhesive: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGX

FDA has decided no KGX device since 2007.

Median 510(k) review, days · KGX

Too few KGX 510(k)s in any year since 2007 to give a median.

Recalls per year · KGX

8in 2025

2007high 8 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KGX

317in 2025

2007high 1,290 (2020) · low 26 (2008)2025

MAUDE reports naming product code KGX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	37
2008	—	0	26
2009	—	0	37
2010	—	8	31
2011	—	4	39
2012	—	2	59
2013	—	0	88
2014	—	0	98
2015	—	3	200
2016	—	0	158
2017	—	0	206
2018	—	0	213
2019	—	1	488
2020	—	0	1,290
2021	—	0	562
2022	—	0	253
2023	—	0	192
2024	—	0	224
2025	—	8	317
2026	—	0	—

What is it indicated for?

The Syvek Patch ™ is intended for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K972914 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972914: Syvek Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972914

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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