510(k) · Cleared

Cleared

Kendall Hydrophilic Powder Wound Dressing

K970266510(k) TraditionalCleared Apr 23, 199790-day reviewClass U

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

Kendall Healthcare Products Co. Div.Of Tyco Health · KGN Wound Dressing With Animal-Derived Material (S)

Cleared on Apr 23, 1997 as substantially equivalent to K945000 (Lange Medical Products, Inc., 1994) after a 90-day review. Its family tree reaches back 1 generation to 1994.

Decided: Apr 23, 1997
Review: 90 days
Class: Class U
Product code: KGN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K945000 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK945000 Multidex Hydrophilic Wound DressingLange Medical Products, Inc. · 1994 · Recalled
This deviceK970266 Kendall Hydrophilic Powder Wound DressingKendall Healthcare Products Co. Div.Of Tyco Health · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945000	Multidex Hydrophilic Wound Dressing	Lange Medical Products, Inc.	1994	1
0 (this device)	K970266	Kendall Hydrophilic Powder Wound Dressing	Kendall Healthcare Products Co. Div.Of Tyco Health	1997	—

FIG. 1 — Lineage of K970266, 1994–1997Source: 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 KGN? 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 KGN device

#1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 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
*	K945000	Multidex Hydrophilic Wound Dressing Summary page 1 …Wound Dressing is substantially equivalent in intended use and composition to the commercially available DeRoyal Multidex® Hydrophilic Powder Wound Dressing, 510(k) No K945000. Dewvice Descnption The proposed Kendall Hydrophilic Powder Wound Dressing is a sterile composition of maltodextnn, sodium algi…	Lange Medical Products, Inc.	1994	1

What descends from it?

No later submission names this one as a predicate yet.

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 a recall.

How does its category compare?

All KGN devices

KGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGN

15so far in 2026, the most since 2007

2007high 15 (2026) · low 3 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KGN

162in 2025

2007high 279 (2020) · low 32 (2007)2026

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

Recalls per year · KGN

3in 2018

2007high 3 (2018) · low 0 (2007)2026

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

Adverse event reports per year · KGN

15in 2025

2007high 21 (2023) · low 0 (2007)2025

MAUDE reports naming product code KGN, 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	3	32	0	0
2008	6	87	0	1
2009	8	121	0	2
2010	4	175	0	3
2011	7	228	0	6
2012	8	123	0	4
2013	6	147	0	6
2014	5	188	0	12
2015	7	87	0	9
2016	4	164	0	6
2017	7	136	1	8
2018	6	148	3	15
2019	3	128	0	11
2020	5	279	0	17
2021	6	236	0	14
2022	12	246	0	13
2023	9	194	0	21
2024	13	83	0	15
2025	10	162	0	15
2026	15	174	0	—

What is it indicated for?

Like the predicate device, the Kendall Hydrophilic Powder Wound Dressing is indicated for the management of exudating wounds such as dermal ulcers (e.g., venous stasis, pressure, arterial, diabetic), surgical incisions, traumatic wounds (e.g., lacerations, abrasions).

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/K970266 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970266: Kendall Hydrophilic Powder Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970266

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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