510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,618

176,415 records, page 2978 of 3529

510(k) clearances, page 2978 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K851382	Chesebrough-Pond's Sequential Wound Dressing	Chesebrough-Pond'S U.S.A. Co.	NAD	Class I	1985-07-05
K851320	Sdi Prepax Dilukit M.	Scientific Distributors, Inc.	GIF	Class I	1985-07-05
K851280	Dass Pack	Dass, Inc.	GIF	Class I	1985-07-05
K851272	Versaphage	Alphamedix, Inc.	HQE	Class II	1985-07-05
K851142	Telet-Lex Medical IV Catheter Placement	Teleflexmedical, Inc.	FOZ	Class II	1985-07-05
K851132	Latex Agglutination Test	New Horizons Diagnostics Co.	GTZ	Class I	1985-07-05
K850889	Bard Occlusive Wound Dressing	C.R. Bard Inc	FRO	Unclassified	1985-07-05
K850147	Cutinova Gelfilm Synthetic Wound Dressing, Sterile	Beiersdorf, Inc.	FRO	Unclassified	1985-07-05
K844244	Derata Medi-Jector Pro	Derata Corp.	KZE	Class II	1985-07-05
K852579	The Suntanning Co. Tanning Bed	The Suntanning Company, Inc.	FTC	Class II	1985-07-03
K851647	Olbert Catheter System for Biliary Tract Dilatatio	Meadox Surgimed, Inc.	FGE	Class II	1985-07-03
K852559	Bone Pin Cutter-18 Inch	The Huxley Instrument Corp.			1985-07-02
K852558	Splints(all Type)	The Huxley Instrument Corp.	FYH	Class I	1985-07-02
K852332	Table Accessories, Operating Room	Scholten Surgical Instruments, Inc.	BWN	Class I	1985-07-02
K852302	Inox Iorceps Jar	Broadwest Corp.			1985-07-02
K852182	Easy Tray & Easy Base Custom Impression Tray Mater	The S. S. White Co.	EBH	Class I	1985-07-02
K852145	Capa Pre-Formed Porcelain Crown	Capa Industries	ELL	Class II	1985-07-02
K852120	Forceps, Biopsy(non Rigid)	Scholten Surgical Instruments, Inc.	GEN	Class I	1985-07-02
K851903	Astra Lightweight Stainless Steel Self Aspir/syrin	Astra Pharmaceutical Products, Inc.	EJI	Class II	1985-07-02
K851872	Blengold Special	Heraeus Dental Gold Corp.	EJT	Class II	1985-07-02
K851870	Mentor Universal Ureteral Stent Set	Mentor	FAD	Class II	1985-07-02
K851730	2710 to 2935 Various Pliers for Orthodontics/prost	Artiberia	EJY	Class I	1985-07-02
K851729	2620/1 to 2635/2 Various Dental Crown Scissors	Artiberia	EIR	Class I	1985-07-02
K851727	2020-1/2 to 2220 Various Dental Wax & Modelling Ca	Artiberia	EIK	Class I	1985-07-02
K851726	1760/1 to 2010/34 Various Dental Filling Instrumen	Artiberia	EIY	Class I	1985-07-02
K851724	1410/1 to 1435/13 Various Probes & Explorers	Artiberia	EKB	Class I	1985-07-02
K851723	1300/10 to 1305/89-92 Various Cutting Instruments	Artiberia	EKD	Class I	1985-07-02
K851722	1285/5 to 1295 Various Types of Dental Excavators	Artiberia	EKC	Class I	1985-07-02
K851721	1200/1 to 1240/15 Various Types of Dental Scalers	Artiberia	EMN	Class I	1985-07-02
K851720	1155/1 to 1162/12 Various Types Gum Scissors	Artiberia	EGN	Class I	1985-07-02
K851719	1070/15 to 1078/17 Various Types Needle Holders	Artiberia	EZZ	Class III	1985-07-02
K851718	930/0 to 950/6 Various Types of Bone Curettes	Artiberia	EMK	Class I	1985-07-02
K851684	Urotec/franklin Soft Simplastic Catheter	Urotec Systems Corp.	KOD	Class II	1985-07-02
K851397	Sonicator 705 Model Me 705	Mettler Electronics Corp	IMI	Class II	1985-07-02
K851381	Power Drive Wheelchair-Various	Everest & Jennings, Inc.	ITI	Class II	1985-07-02
K851339	Precision Harvest & Inlay Instrument Set	Concept, Inc.	HWK	Class I	1985-07-02
K851319	Dialysis Concentrate	Ries Biologicals			1985-07-02
K851251	Auto/manual Titanium Hemoclip Ligating Clip 527200	Edward Weck, Inc.	FZP	Class II	1985-07-02
K850927	Complete Denture Repair Kit	Tooth Aid Lab, Inc.	EBO	Class II	1985-07-02
K850329	Cordia S4 -Treponema Pallidum	Cordis US Corp.	LIP	Class II	1985-07-02
K852540	Ultrasonic Tooth Scaler Model Dsciop	Parkell, Inc.	ELC	Class II	1985-07-01
K852504	Ohmeda Cpu Monitor	GE Healthcare			1985-07-01
K852489	Propol Dental Polishing Paste	Scientific Pharmaceuticals, Inc.	EJR	Class I	1985-07-01
K852474	Union Broach Bleaching Light	Union Broach, Div. Moyco Industries, Inc.			1985-07-01
K852400	Plak Smacker	Plak Smacker Toothbrush Co.	EFW	Class I	1985-07-01
K852344	Distalite Posteria Dental Restorative	Johnson & Johnson Professionals, Inc.	EBF	Class II	1985-07-01
K852337	Pneumoscope	Erich Jaeger, Inc.	BZG	Class II	1985-07-01
K852301	Inox Thermometer Jar	Broadwest Corp.	FLK	Class II	1985-07-01
K852279	Sunbeam Rechargeable Toothbrush Model # 4201	Northern Electric Co. Div. of Sunbeam Corp.	JEQ	Class I	1985-07-01
K852180	Surgidynes Varidyne 350-2I & 350-2C Cordless Elec.	Surgidyne, Inc.			1985-07-01