510(k) · Cleared

Cleared

3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing

K980989510(k) TraditionalCleared May 27, 199872-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

Innovative Technologies, Ltd. · KMF Bandage, Liquid

Cleared on May 27, 1998 as substantially equivalent to K953781 (Innovative Technologies, Ltd., 1995) after a 72-day review. Its family tree reaches back 1 generation to 1995. 37 later devices descend from it.

Decided: May 27, 1998
Review: 72 days
Class: Class I
Product code: KMF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K953781 (1995). 37 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
This deviceK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
Descendant · cites it directly · 35 of its ownK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
Descendant · 2 generations on · 23 of its ownK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
Descendant · 3 generations on · 17 of its ownK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
Descendant · 4 generations on · 16 of its ownK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
Descendant · 3 generations on · 14 of its ownK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

1998high 4 (2007) · low 0 (1999)2026

Most influential descendants

Showing 5 of 37 · See all

K010933Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002 · cites it directly35descendants
K024107Femostop Femoral Compression SystemRadi Medical Systems AB · 2002 · 2 generations on23descendants
K040730Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004 · 3 generations on17descendants
K050146Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005 · 4 generations on16descendants
K053300SyvekexcelMarine Polymer Technologies, Inc. · 2006 · 3 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K953781	Innovative Technologies Calcium Alginate Wound Dressings	Innovative Technologies, Ltd.	1995	—
0 (this device)	K980989	3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing	Innovative Technologies, Ltd.	1998	—
+1	K010933	Seal-on Topical Hempstatic Powder Spray	Alltracel Pharma, Ltd.	2002	—
+2	K024107	Femostop Femoral Compression System	Radi Medical Systems AB	2002	—
+3	K040730	Vascular Solutions D-Stat Clamp Hemostatic Clamp	Vascular Solutions, Inc.	2004	—
+4	K050146	Vascular Solutions D-Stat Clamp Accessory	Vascular Solutions, Inc.	2005	—
+3	K053300	Syvekexcel	Marine Polymer Technologies, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2002	2	0
2004	2	0
2005	1	0
2006	2	0
2007	4	0
2008	2	0
2009	1	0
2010	2	0
2011	3	0
2012	4	0
2013	1	0
2015	1	0
2016	3	0
2018	2	0
2019	1	0
2020	1	0
2022	1	0
2023	2	0
2024	1	0

FIG. 1 — Lineage of K980989, 1995–2024Source: 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 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 K241916 TearRepair Liquid Skin Protectantscore 8.1 · 1 generation · no Class I recall

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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
*	K953781	Innovative Technologies Calcium Alginate Wound Dressings Summary page 1 …ol minor bleeding. This product is not designed, sold, or intended for use except as indicated. Substantial Equivalence: Substantial equivalence was provided in 510(k) K953781. Testing Summary: Biocompatibility test results presented in Attachment 4 support the safety of this product for it’s stated in…	Innovative Technologies, Ltd.	1995	—

Also cleared against K953781: 2 other devices →

What descends from it? (37)

See all 37

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

Number	Device	Applicant	Decided	Descendants
K010933	Seal-on Topical Hempstatic Powder Spray	Alltracel Pharma, Ltd.	2002	35
K982638	3M Tegagen HI Alginate Dressing & 3 M Tegagen HG Alginate Dressing, Model #'S…	Innovative Technologies, Ltd.	1998	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, K010933 (Alltracel Pharma, Ltd., 2002) has gone furthest, with 35 descendants of its own.
2 other devices also cite its predicate K953781.

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

2007high 3 (2008) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KMF

213in 2009

2007high 213 (2009) · low 35 (2008)2026

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

Recalls per year · KMF

1in 2011

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	1	6
2008	3	35	0	2
2009	3	213	0	6
2010	1	—	0	7
2011	0	—	1	16
2012	1	—	0	3
2013	0	—	0	34
2014	2	—	0	24
2015	0	—	0	13
2016	2	—	0	18
2017	0	—	0	16
2018	1	—	0	10
2019	1	—	0	6
2020	0	—	0	8
2021	0	—	0	10
2022	0	—	0	7
2023	0	—	0	6
2024	1	—	0	6
2025	0	—	0	12
2026	0	—	0	—

What is it indicated for?

Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg:

Pressure ulcers

Venous ulcers

Diabetic ulcers

Superficial wounds; such as cuts and abrasions

Donor wounds

Post-operative wounds

Trauma wounds

Dermal lesions

Tegagen HI & HG alginate dressings are also intended to help control minor bleeding.

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/K980989 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980989: 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980989

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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