510(k) · Cleared

Cleared

Dryodine Cadexomer-Iodine Gel

K093320510(k) TraditionalCleared Jun 18, 2010238-day reviewClass U

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

Collegium Pharmaceutical Incorporated · FRO Dressing, Wound, Drug

Cleared on Jun 18, 2010 as substantially equivalent to K905069 (Perstorp AB C/O Robert Joel Slomoff, 1991) and 1 other predicate after a 238-day review. Its family tree reaches back 2 generations to 1994.

Decided: Jun 18, 2010
Review: 238 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K940414 (1994). 4 ancestors in all, the oldest K905069 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK940414 Iodoflex PasteOclassen Pharmaceuticals, Inc. · 1994
1 generation backK051542 Triosyn T40 Antimicrobial Wound DressingTriosyn Corp. · 2006
This deviceK093320 Dryodine Cadexomer-Iodine GelCollegium Pharmaceutical Incorporated · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K940414	Iodoflex Paste	Oclassen Pharmaceuticals, Inc.	1994	—
−1	K051542	Triosyn T40 Antimicrobial Wound Dressing	Triosyn Corp.	2006	—
0 (this device)	K093320	Dryodine Cadexomer-Iodine Gel	Collegium Pharmaceutical Incorporated	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0
2000	1	0

FIG. 1 — Lineage of K093320, 1994–2010Source: 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

Get a 510(k) Report

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
*	K905069	Iodosorb Gel Summary page 1 …DryodineTm Antibacterial Gel is substantially equivalent to the following predicate devices: - o Iodosorb Gel cleared under 510(k) K905069, from Perstorp Pharmna. o Triosyn T40 Antimicrobial Dressing under 510(k) KO5 1452, from Triosyn Corporation…	Perstorp AB C/O Robert Joel Slomoff	1991	—
*	K051542	Triosyn T40 Antimicrobial Wound Dressing Our reading of the summary gave K051452, FDA’s number for Sentinel Clin Chem Cal (Sentinel Ch. Srl). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Triosyn T40 Antimicrobial Dressing”.	Triosyn Corp.	2006	—

Also cleared against K905069: 2 other devices →

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?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 11.9 years on median.
None of the 4 ancestors has a recall.
2 other devices also cite its predicate K905069.

How does its category compare?

All FRO devices

FRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?

DryodineTM Antibacterial Gel is indicated for use in the management/cleaning of wet ulcers and wounds such as venous stasis ulcers, pressure sores, diabetic foot ulcers, and traumatic and surgical wounds. DryodineTm Antibacterial Gel assists to keep lesions soft and pliable.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093320 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093320: Dryodine Cadexomer-Iodine Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093320

Report an extraction error

Are you the manufacturer?

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