510(k) · Cleared

Cleared

Dermaphylyx Calcium Alginate Wound Dressing

K991608510(k) TraditionalCleared Jul 20, 199971-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

Cleared on Jul 20, 1999 after a 71-day review. The FDA summary names its predicate without a number. 51 later devices descend from it.

Decided: Jul 20, 1999
Review: 71 days
Class: Class I
Product code: KMF
Recalls: None
Predicates: 0

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

This deviceK991608 Dermaphylyx Calcium Alginate Wound DressingDermaphylyx, Inc. · 1999
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 · cites it directly · 14 of its ownK081584 Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008

Showing 5 of 51 descendants. See all descendants

Descendants cleared per year

2002high 6 (2011) · low 0 (2003)2026

Most influential descendants

Showing 5 of 51 · 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
K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · cites it directly14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K991608	Dermaphylyx Calcium Alginate Wound Dressing	Dermaphylyx, Inc.	1999	—
+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	—
+1	K081584	Derma Sciences Otc Medihoney Dressings with Active Manuka Honey	Derma Sciences, Inc.	2008	—

Descendants by year cleared

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

FIG. 1 — Lineage of K991608, 1999–2026Source: 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 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? (2)

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
*	—	Innovative Technologies Calcium Alginate Wound Dressings (Innovative Technologies Group… Named without a submission number			—
*	—	Kaltostat® Calcium Alginate Wound Dressings (Calgon Vestal Laboratories) Named without a submission number			—

What descends from it? (51)

See all 51

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
K081584	Derma Sciences Otc Medihoney Dressings with Active Manuka Honey	Derma Sciences, Inc.	2008	14

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, K010933 (Alltracel Pharma, Ltd., 2002) has gone furthest, with 35 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

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?

Dermaphylyx Calcium Alginate Wound Dressings are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minot bleeding by application of pressure to the wound.

The following Indications are for Prescription Use or under the direction of a health care professional:

Venous ulcers Superficial bums

Diabctic ulcers Abrasions and laccrations

Pressure ulcers Donor sites

Artcrial ulcers Postoperative wounds

The following Indications are for Over-the-Counter Usc:

Abrasions

Minor Bums

Minor Cuts

Minor Laccrations

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/K991608 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991608: Dermaphylyx Calcium Alginate Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991608

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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