510(k) · Cleared

Recalled · Class III · 2022

Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver (Algicell AG)

K080497510(k) TraditionalCleared Jun 27, 2008126-day reviewClass URecalls 1

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

Derma Sciences Canada, Inc. · FRO Dressing, Wound, Drug

Cleared on Jun 27, 2008 as substantially equivalent to K052536 (Derma Sciences Canada, Inc., 2006) after a 126-day review. Its family tree reaches back 1 generation to 2006. It has been recalled once.

Decided: Jun 27, 2008
Review: 126 days
Class: Class U
Product code: FRO
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K052536 (2006). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK052536 Algicell AGDerma Sciences Canada, Inc. · 2006
This deviceK080497 Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver…Derma Sciences Canada, Inc. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K052536	Algicell AG	Derma Sciences Canada, Inc.	2006	—
0 (this device)	K080497	Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver (Algicell AG)	Derma Sciences Canada, Inc.	2008	—

FIG. 1 — Lineage of K080497, 2006–2008Source: 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 FRO? 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 FRO device

#1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 14 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
*	K052536	Algicell AG Summary page 1 …Classification Name: Dressing 3. PREDICATE DEVICES: Calcium Alginate Dressing with Antimicrobial Silver (K052536) 4. DEVICE DESCRIPTION: Calcium Alginate Dressing with Antimicrobial Silver is a p…	Derma Sciences Canada, Inc.	2006	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 25, 2022	Class III	Z-1800-2022	Environmental control	Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · FRO

11in 2025

2007high 31 (2009) · low 8 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRO

176in 2025

2007high 332 (2022) · low 96 (2012)2026

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

Recalls per year · FRO

2in 2024

2007high 6 (2021) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · FRO

192in 2025

2007high 297 (2015) · low 30 (2008)2025

MAUDE reports naming product code FRO, 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	29	187	4	55
2008	26	130	1	30
2009	31	136	1	45
2010	31	146	0	122
2011	27	177	4	42
2012	24	96	0	65
2013	19	194	1	139
2014	22	214	1	269
2015	28	249	2	297
2016	28	222	3	147
2017	23	147	1	149
2018	20	206	0	128
2019	16	270	1	136
2020	12	226	0	139
2021	8	275	6	183
2022	9	332	2	176
2023	18	283	2 (2)	198
2024	24	263	2	232
2025	11	176	0	192
2026	17	254	2	—

What is it indicated for?

For over-the-counter use, Calcium Alginate Dressing with Antimicrobial Silver may be used for:

- abrasions

- minor lacerations

- minor cuts

- minor scalds and burns

Under the supervision of a healthcare professional, Algicell®Ag (Calcium Alginate Dressing with Antimicrobial Silver) dressing is an effective barrier to bacterial penetration in moderate to heavily exuding wound such as:

* diabetic foot ulcer

* leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology

* pressure ulcers/sores (partial and full thickness)

* donor sites, and traumatic and surgical wounds.

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/K080497 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080497: Derma Sciences Calcium Alginate Dressing with Antimicrobial Silver (Algicell AG).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080497

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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