FRO · Dressing, Wound, Drug · Chrysalis Intelligence

Device class

Unclassified

Regulation —

Total clearances

2020-02-07 → 2026-08-14

Last 12 months

Unique sponsors

Classification details

Medical specialty

Unknown

Review panel

Regulation number

—

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Winner Medical Co., Ltd.	11	0	2023-12-01
Huizhou Foryou Medical Devices Co., Ltd.	10	1	2025-11-19
Advanced Medical Solutions Limited	3	0	2023-10-26
Sonoma Pharmaceuticals, Inc.	3	1	2026-06-24
Kane Biotech, Inc.	3	1	2026-01-08
Roosin Medical Co., Ltd.	2	0	2024-01-11
Beijing Kreate Medical Co., Ltd.	2	2	2026-08-14
Stemcyte, Inc.	2	0	2024-05-22
Sioxmed, LLC	2	1	2026-01-12
Mebo Life Science, Inc.	2	0	2022-10-18
Bionova Medical, Inc.	2	0	2024-10-31
Argentum Medical, Inc.	2	0	2024-07-31
Oneness Biotech Co., Ltd.	2	1	2026-06-17
Innovacyn, Inc.	2	1	2026-01-05
Qingdao Bright Moon Biomedical Materials Co., Ltd.	2	1	2025-12-19
Next Science, LLC	2	0	2021-09-23
Huizhou Foryou Medical Co., Ltd.	1	1	2026-03-11
Rapid Nexus Nanotech Wound Solutions, Inc.	1	1	2025-10-14
Irrimax Corporation	1	0	2024-06-18
Urgo Medical North America, LLC	1	1	2026-08-11
3-D Matrix, Inc.	1	0	2020-05-11
Hartmann USA, Inc.	1	0	2024-12-09
InnovaCorium, Inc.	1	1	2026-04-07
Coloplast Corp.	1	0	2024-03-22
Sweetbio, Inc.	1	0	2023-10-13

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-08-14	K261646	Beijing Kreate Medical Co., Ltd.	Redermax® Antibacterial Wound Matrix
2026-08-11	K253665	Urgo Medical North America, LLC	Vashe Plus Antimicrobial Solution
2026-06-24	K261023	Sonoma Pharmaceuticals, Inc.	Microdacyn Wound Irrigation Solution
2026-06-24	K251929	Silverceuticals, Inc.	SilverCeuticals® Antimicrobial Wound Gel
2026-06-17	K261638	Oneness Biotech Co., Ltd.	Bonvadis®
2026-05-13	K254073	Merit Medical Systems, Inc.	StatSeal Disc
2026-04-07	K254191	InnovaCorium, Inc.	IWD-Gel
2026-03-25	K252023	Letus Corporation	MiraChlor Antimicrobial Wound Solution
2026-03-13	K251999	Solventum Germany GmbH	Promogran Prisma Collagen Matrix with ORC and Silver
2026-03-11	K252028	Huizhou Foryou Medical Co., Ltd.	LUOFUCON® Antimicrobial Wound Gel
2026-02-02	K251582	Beijing Kreate Medical Co., Ltd.	Redermax Antibacterial Wound Matrix
2026-01-23	K252568	Silk Holdings, Inc.	New Day Skin Spray
2026-01-12	K250890	Sioxmed, LLC	SBC1 Cream
2026-01-08	K252759	Kane Biotech, Inc.	revyve® Antimicrobial Skin and Wound Cleanser
2026-01-05	K251757	Innovacyn, Inc.	Puracyn® Plus Antimicrobial Irrigation Solution
2025-12-19	K252167	Qingdao Bright Moon Biomedical Materials Co., Ltd.	Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription)
2025-11-19	K250642	Huizhou Foryou Medical Devices Co., Ltd.	LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
2025-10-14	K250115	Rapid Nexus Nanotech Wound Solutions, Inc.	Hemastyl() Wound Dressing
2025-10-10	K251866	Solventum US, LLC	Tegaderm Post-Op Transparent Antimicrobial Dressing
2025-08-27	K243166	Infection Elimination Solutions, LLC	Dermalage
2025-07-22	K243415	P.G.F. Industry Solutions GmbH	Granudacyn® Wound Irrigation Solution
2025-06-09	K251093	Oneness Biotech Co., Ltd.	Bonvadis®
2025-05-02	K243457	Seriously Clean, Ltd.	Nixall Antimicrobial Solutions Skin & Wound Hydrogel
2025-04-21	K243875	Spectrum Antimicrobials, Inc.	Spectricept Skin and Wound Cleanser
2025-03-13	K242406	Sioxmed, LLC	SiOxC Cream