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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2247 of 3531

510(k) clearances, page 2247 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K934428	Argyle Turkel Safety Pneumothorax Procedure Tray	Sherwood Medical Co.	LRO	Class II	1993-12-30
K933884	Strato Medical Lifeport Lps 7255 Low Profile Dual Lumen Vascular Access System	Strato Medical Corp.	LJS	Class II	1993-12-30
K931873	Vacvent	Steven Frank Mercereau	CBT	Class I	1993-12-30
K931673	Carapace Cataract Trays	Carapace, Inc.	LRO	Class II	1993-12-30
K930125	Phoenix Bone Screws Pbs-Type Series	Phoenix Bioengineering, Inc.	HXA	Class II	1993-12-30
K922730	Lake Ostomy Care Set	Lake Medical Products, Inc.	EXB	Class I	1993-12-30
K935652	Namtai	Nam Tai Electronics (Canada), Ltd.	DXN	Class II	1993-12-29
K935320	Phencyclidine Eia Assay	Diagnostic Reagents, Inc.	LCM	Unclassified	1993-12-29
K934930	Olympic Auto-Length	Olympic Medical Corp.	FTY	Class I	1993-12-29
K934923	Clearview Positive and Negative Urine Hcg Contol Set	Unipath, Ltd.	JJX	Class I	1993-12-29
K934922	Clearview Positive and Negative Hcg Urine Control Set	Unipath, Ltd.	JJX	Class I	1993-12-29
K934168	Cedia Digoxin Plus Assay	Microgenics Corporation	KXT	Class II	1993-12-29
K934062	Biotrack Therapeutic Drug-Monitoring Qual Controls	Biotrack, Inc.	DIF	Class I	1993-12-29
K934061	Biotrack Valproic Acid Test Cartridge	Biotrack, Inc.	LEG	Class II	1993-12-29
K933895	Phx Technologies Corp., Grasper-Retractor Device	Phx Technologies Corp.	GCJ	Class II	1993-12-29
K933852	Pro-Lok Extension Set	Beech Medical Products, Inc.	FPA	Class II	1993-12-29
K933749	Beech Versa Lok	Beech Medical Products, Inc.	FPA	Class II	1993-12-29
K933732	Beech Prolok	Beech Medical, Inc.	FPA	Class II	1993-12-29
K933625	Brat 2 Autologus Blood Salvage System	LivaNova USA, Inc.	CAC	Class II	1993-12-29
K932548	Abuscreen Online Low-Cutoff Calibrators	Roche Diagnostic Systems, Inc.	DLJ	Class II	1993-12-29
K930500	Maxiview Diagnostic Workstation	Dimensional Medicine, Inc.	LMD	Class I	1993-12-29
K934212	Fast Spin Echo	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1993-12-27
K934149	Micro-Tech Tru Canal	Micro-Ear Technology, Inc.	ESD	Class I	1993-12-27
K933872	Visi-Spear Eye Sponge	Visitec Co.	HOZ	Class II	1993-12-27
K933844	Para 4 Plus	Streck Laboratories, Inc.	JJY	Class I	1993-12-27
K933746	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JWY	Class II	1993-12-27
K933724	Sensor-Tip Trocar	Origin Medsystems, Inc.	GCJ	Class II	1993-12-27
K933709	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JWY	Class II	1993-12-27
K933236	Cordis Opta 5(Tm), Modification	Cordis US Corp.	LIT	Class II	1993-12-27
K932954	Avoximeter	A-Vox Systems, Inc.	DQK	Class II	1993-12-27
K932704	Patient Cable	Sentry Medical Products, Inc.	DSA	Class II	1993-12-27
K932692	Innerdyne Medical Laparoscopic Sphincterotomy Kit	Innerdyne Medical, Inc.	GCJ	Class II	1993-12-27
K932422	3M Tegaderm Hp Transparent Dressing	3M Company	KGX	Class I	1993-12-27
K932384	Ideia(tm) Rotavirus	Dako Diagnostics, Ltd.	LIQ	Class I	1993-12-27
K932101	Duoderm Improved Cgf Control Gel Formula Dressing	Convatec, A Division of E.R. Squibb & Sons	MGQ	Unclassified	1993-12-27
K930778	Immunocard Mono	Meridian Diagnostics, Inc.	KTN	Class II	1993-12-27
K935310	Medical Laser Mixture	Acetylene Gas Co.	GEX	Class II	1993-12-23
K935260	Physiometrix Cable Adapter Modification	Physiometrix, Inc.	IKD	Class II	1993-12-23
K934739	Davinci Cholangiogram Delivery Device	Da Vinci Medical, Inc.	GCJ	Class II	1993-12-23
K934724	Aesculap Trocar Instrument Set	Aesculap Inc	FBQ	Class II	1993-12-23
K934499	Magnetic Resonance Diagnostic Accessory	GE Healthcare	LNH	Class II	1993-12-23
K933686	Look Inc. 316L Stainless Steel Surgical Suture	Look, Inc.	GAQ	Class II	1993-12-23
K933085	Goodman Bandage	Megadyne Medical Products, Inc	KGY	Class I	1993-12-23
K926230	Epidress & Dermasorb Hydrocolloid Alginate Dressin	Convatec, A Division of E.R. Squibb & Sons	KMF	Class I	1993-12-23
K924177	Confort	Scott Paper Co.	HHD	Class I	1993-12-23
K924176	Saba Intima	Scott Paper Co.	HHD	Class I	1993-12-23
K924175	Saba Confort	Scott Paper Co.	HHD	Class I	1993-12-23
K923568	Trocar Stability Thread	Applied Medical Resources Corp	HET	Class II	1993-12-23
K920664	Diagnostic Ultrasound/uro-Gyn Ups 2020, Gi Version	Diagnostic Ultrasound Corp.	FFX	Class II	1993-12-23
K935311	Clinical Blood Gas	Acetylene Gas Co.	BXK	Class I	1993-12-22