510(k) Report

510(k) · Cleared

Cleared

Modification to Skvekpatch

K984177510(k) TraditionalCleared Dec 18, 199828-day reviewClass I21 CFR 880.5090

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. · KMF Bandage, Liquid

Cleared on Dec 18, 1998 after a 28-day review. The FDA summary names no predicate by number. 120 later devices descend from it.

Decided
Dec 18, 1998
Review
28 days
Class
Class I
Product code
KMF
Recalls
None
Predicates
0

120 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2003: 4 descendants cleared2007: 11 descendants cleared2004: 3 descendants cleared2002: 2 descendants cleared2015: 8 descendants cleared2006: 3 descendants cleared2011: 6 descendants cleared2008: 6 descendants cleared2005: 5 descendants cleared2009: 8 descendants cleared2016: 5 descendants cleared2012: 3 descendants cleared2010: 7 descendants cleared2013: 5 descendants cleared2018: 6 descendants cleared2023: 7 descendants cleared2014: 7 descendants cleared2022: 3 descendants cleared2021: 1 descendant cleared2019: 5 descendants cleared2020: 2 descendants cleared2024: 4 descendants cleared2017: 4 descendants cleared2026: 3 descendants cleared2025: 2 descendants cleared1995200020052010201520202025
  1. This deviceK984177 Modification to SkvekpatchMarine Polymer Technologies, Inc. · 1998
  2. Descendant · cites it directly · 56 of its ownK030946 Hemcon Bandage Otc; Hemcon Cath/AidHemcon, Inc. · 2003
  3. Descendant · 2 generations on · 55 of its ownK043050 Hemcon Bandage and Hemcon Bandage OtcHemcon, Inc. · 2005
  4. Descendant · cites it directly · 48 of its ownK021062 Chito-SealAbbott Vascular, Inc. · 2002
  5. Descendant · cites it directly · 45 of its ownK012293 Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002
  6. Descendant · 2 generations on · 44 of its ownK030836 D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · Recalled

Showing 5 of 120 descendants. See all descendants

Descendants cleared per year

2002: 22003: 42004: 32005: 52006: 32007: 112008: 62009: 82010: 72011: 62012: 32013: 52014: 72015: 82016: 52017: 42018: 62019: 52020: 22021: 12022: 32023: 72024: 42025: 22026: 3
2002high 11 (2007) · low 1 (2021)2026

Most influential descendants

Showing 5 of 120 · See all
  • K030946Hemcon Bandage Otc; Hemcon Cath/AidHemcon, Inc. · 2003 · cites it directly56descendants
  • K043050Hemcon Bandage and Hemcon Bandage OtcHemcon, Inc. · 2005 · 2 generations on55descendants
  • K021062Chito-SealAbbott Vascular, Inc. · 2002 · cites it directly48descendants
  • K012293Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc. · 2002 · cites it directly45descendants
  • K030836D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc. · 2003 · 2 generations on44descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K984177Modification to SkvekpatchMarine Polymer Technologies, Inc.1998—
+1K030946Hemcon Bandage Otc; Hemcon Cath/AidHemcon, Inc.2003—
+2K043050Hemcon Bandage and Hemcon Bandage OtcHemcon, Inc.2005—
+1K021062Chito-SealAbbott Vascular, Inc.2002—
+1K012293Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc.2002—
+2K030836D-Stat-Dry Hemostatic Bandage; D-Stat Radial Hemostatic BandageVascular Solutions, Inc.20033

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200340
200430
200550
200630
2007110
200860
200980
201070
201160
201230
201350
201470
201580
201650
201740
201860
201950
202020
202110
202230
202370
202440
202520
202630
FIG. 1 — Lineage of K984177, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KMF? 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 KMF device

  1. #1 K241916 TearRepair Liquid Skin Protectantscore 8.1 · 1 generation · no Class I recall
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (120)

See all 120

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

NumberDeviceApplicantDecidedDescendants
K030946Hemcon Bandage Otc; Hemcon Cath/AidHemcon, Inc.200356
K021062Chito-SealAbbott Vascular, Inc.200248
K012293Vascular Solutions Duett Flowable HemostatVascular Solutions, Inc.200245
K030334T-Scientific T-PadT-Scientific, Inc.200344
K033666HemadermMedafor, Inc.200329
K032986Clo-Surplusp.a.D.Scion Cardio-Vascular, Inc.200425
K053300SyvekexcelMarine Polymer Technologies, Inc.200614
K040208Neptune Pad, Neptune Disc, Neptune Comfort-Band, Comfort-BandTz Medical, Inc.200414
K070557MP 719Marine Polymer Technologies, Inc.20072
K143466Hemogrip PatchRemedium Technologies, Inc.20150

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, K030946 (Hemcon, Inc., 2003) has gone furthest, with 56 descendants of its own.

How does its category compare?

All KMF devices

KMF Bandage, Liquid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KMF

1in 2024

2007: 22008: 32009: 32010: 12012: 12014: 22016: 22018: 12019: 12024: 1
2007high 3 (2008) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KMF

213in 2009

2008: 35 days median2009: 213 days median
2007high 213 (2009) · low 35 (2008)2026

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

Recalls per year · KMF

1in 2011

2007: 12011: 1
2007high 1 (2007) · low 0 (2008)2026

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

Adverse event reports per year · KMF

12in 2025

2007: 62008: 22009: 62010: 72011: 162012: 32013: 342014: 242015: 132016: 182017: 162018: 102019: 62020: 82021: 102022: 72023: 62024: 62025: 12
2007high 34 (2013) · low 2 (2008)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—16
200833502
2009321306
20101—07
20110—116
20121—03
20130—034
20142—024
20150—013
20162—018
20170—016
20181—010
20191—06
20200—08
20210—010
20220—07
20230—06
20241—06
20250—012
20260—0—

What is it indicated for?

ProDein™Patch is indicated for use in the local management of bleeding wounds such as lacerations, abrasions and nose bleeds.

SyvekPatch™ is intended for use under the direction of a healthcare professional for the following indications:

SyvekPatch™ is indicated for the promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.

SyvekPatch™ is indicated for use in the local management of bleeding wounds such as vascular access site, percutaneous catheters or tubes and surgical debridement.

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

More from Marine Polymer Technologies, Inc.

8 FDA decisions under this applicant name. See the company

  • K160695Talymed SuspensionMarine Polymer Technologies, Inc. · 2016
  • K111524MP 719Marine Polymer Technologies, Inc. · 2011
  • K082703MRDH BandageMarine Polymer Technologies, Inc. · 2008
  • K070557MP 719Marine Polymer Technologies, Inc. · 2007
  • K053300SyvekexcelMarine Polymer Technologies, Inc. · 2006

Recent decisions in KMF

The KMF category page

  • K241916TearRepair Liquid Skin ProtectantOptmed, Inc. · 2024
  • K182733Rochal Bioshield Silicone FilmRochal Industries, LLC · 2019
  • K171148Aleo BME Liquid BandageAleo Bme, Inc. · 2018
  • K153571Cavilon Advanced High Endurance Skin Protectant3M Healthcare · 2016
  • K160684Atteris No-Sting Skin ProtectantRochal Industries, LLC · 2016

https://510kreport.com/device/K984177 · printed Nov 5, 2026

Cite this page

510(k) Report. “K984177: Modification to Skvekpatch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984177

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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