510(k) · Cleared

Cleared

Catasyn Advanced Technology Wound Hydrogel

K172338510(k) TraditionalCleared Feb 21, 2018203-day reviewClass U

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

Synedgen, Inc. · FRO Dressing, Wound, Drug

Cleared on Feb 21, 2018 as substantially equivalent to K973725 (Fidia Pharmaceutical Corp., 1998) and 1 other predicate after a 203-day review. Its family tree reaches back 1 generation to 1998.

Decided: Feb 21, 2018
Review: 203 days
Class: Class U
Product code: FRO
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K973725 (1998). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK973725 Bionect Clear HydrogelFidia Pharmaceutical Corp. · 1998
This deviceK172338 Catasyn Advanced Technology Wound HydrogelSynedgen, Inc. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K973725	Bionect Clear Hydrogel	Fidia Pharmaceutical Corp.	1998	—
0 (this device)	K172338	Catasyn Advanced Technology Wound Hydrogel	Synedgen, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K172338, 1998–2018Source: 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? (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
*	K973725	Bionect Clear Hydrogel Summary page 4 …mon or Usual name: Hydrogel Wound Dressing Classification: Unclassified Product Code: FRO Primary Predicate Device: Bionect Clear Hydrogel (K973725 RX) (K984264 OTC) (FRO) This predicate has not been subject to a design-related recall. Reference Predicate Devices:…	Fidia Pharmaceutical Corp.	1998	—
*	K984264	Modification of Bionect Clear Hydrogel Summary page 4 …name: Hydrogel Wound Dressing Classification: Unclassified Product Code: FRO Primary Predicate Device: Bionect Clear Hydrogel (K973725 RX) (K984264 OTC) (FRO) This predicate has not been subject to a design-related recall. Reference Predicate Devices: SynePure (…	Fidia Pharmaceutical Corp.	1999	—
†	K143444	SynePure Wound Cleanser	Synedgen, Inc.	2015	—
†	K143527	IPM Wound Gel Bio, IPM Derm Gel Bio	Glycobiosciences, Inc.	2015	—
†	K160192	Atteris Antimicrobial Skin & Wound Cleanser	Rochal Industries, LLC	2016	—
†	K041342	Impruv a.I. Cream Wound and Skin Emulsion	Stiefel Laboratories, Inc.	2005	—

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?

None of the 2 ancestors has a 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. 2018, 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?

Catasyn OTC is indicated for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin.

Catasyn may be used under the direction of a health care professional for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites) and superficial and partial thickness (second degree) burns.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K172338 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172338: Catasyn Advanced Technology Wound Hydrogel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172338

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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