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 2927 of 3529

510(k) clearances, page 2927 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K854613	Surgical Drapes, Ophthalmin	Charles Atkins & Co.	HMT	Class II	1986-02-13
K854534	Digital Screening Audiometer Dsa6214	Madsen Electronics (Canada), Ltd.	EWO	Class II	1986-02-13
K854471	Portalase 300 Carbon Dioxide Surg Laser Ear/nose/t	Minnesota Laser Corp.	EWG	Class II	1986-02-13
K854428	Vasc-Ez	Barton-Carey Medical Products, Inc.	DWL	Class II	1986-02-13
K854157	Pmt Accupressure Infusion System 3601	Progress Mankind Technology	FRN	Class II	1986-02-13
K853737	Vest(ambulatory Ventricular Evaluating System)	Mirion Technologies (Capintec), Inc.	IYY	Class I	1986-02-13
K853702	Ultrasound Couplant Sheet/solid Ultrasound Couplan	Johnson & Johnson Professionals, Inc.	IYO	Class II	1986-02-13
K853580	Medilas 2	Endo Lase, Inc.	LKW	Class III	1986-02-13
K844844	Espe Nimetic-Grip	Espe GmbH (US)	DYH	Class II	1986-02-13
K860436	Ivac Model 2080 Electronic Thermometer	Y	FLL	Class II	1986-02-12
K860434	Chemo-Vent	Intl. Medical Industries	LHI	Class II	1986-02-12
K860347	Sunlamp Models 24N, 30R, 30Re, 37Re	Gti, Inc.	FTC	Class II	1986-02-12
K860331	Disposable Surgical Knife	Med-Tech Develoment Corp.	HNN	Class I	1986-02-12
K860330	Maklakov Style Tonometer	Med-Tech Develoment Corp.	HKY	Class II	1986-02-12
K860329	Fyodorov Radial Keratotomy Marker Set	Med-Tech Develoment Corp.	HHR	Class II	1986-02-12
K860305	Beaver Micro-Gem Gauge Block	Rudolph Beaver, Inc.	HNN	Class I	1986-02-12
K860144	Sum Tan VI	Nae, Inc.	FTC	Class II	1986-02-12
K860113	Double-Ject Transfer Needle	Medimix Products, Inc.	LHI	Class II	1986-02-12
K860103	Mod. Endoport Single-Use Trocar and Sleeve	Endotherapeutics	GCP	Class II	1986-02-12
K860102	Mod. Endoneedle Single-Use Pneumoperitoneum Needle	Endotherapeutics	FHP	Class II	1986-02-12
K860030	Surgidyne Varidyne, Model 140-2I & Model 140-2Id	Surgidyne, Inc.	BTA	Class II	1986-02-12
K855218	Rondex CPR Valve	Kondex Products, Inc.	CBP	Class II	1986-02-12
K855162	Ultraviolet Sun Tanning Unit Kettler Holiday Solar	Mottek Intl. Corp.	FTC	Class II	1986-02-12
K855161	Upright Bucky Stand/mount	X-Ray Systems	KPR	Class II	1986-02-12
K855094	Fukuda Denshi Althus 5100 Patient Monitoring/data	Fukuda Denshi USA, Inc.	DSI	Class II	1986-02-12
K855055	Pds 9000 Patient Data Mgmt. System	Marquette Electronics, Inc.	DQK	Class II	1986-02-12
K855004	Swell-Relief	D.A. Schulman, Inc.	DRM	Class II	1986-02-12
K855000	Rateminder III Infusion Device	American Edwards Laboratories	LDR	Class II	1986-02-12
K854997	Implantable Electrode Adaptor Assembly	Telectronics, Inc.	DTD	Class II	1986-02-12
K854933	Sandhill Electronic Caliper	Sandhill	IXC	Class I	1986-02-12
K854863	Flo-Gard 4000 Volumetric Infusion Controller	Travenol Laboratories, S.A.	LDR	Class II	1986-02-12
K854844	Ls1000 Surgical Aspirator II	Engineering, Inc.	BTA	Class II	1986-02-12
K854804	Multiple i.v. Sets	C. B. Dumont Company, Inc.	FPA	Class II	1986-02-12
K854775	Empi Model 730 Nms	Empi	IPF	Class II	1986-02-12
K854774	Empi Model 720 Nms	Empi	IPF	Class II	1986-02-12
K854459	Tbx Medical X-Ray Table	Gendex Corp.	IXJ	Class I	1986-02-12
K854410	Veriflex	Old Delft Corp. of America	KPZ	Class II	1986-02-12
K853250	Femorotibial Medullary Nail	Zimmer GmbH	HSB	Class II	1986-02-12
K852137	Fenlin Total Shoulder	Zimmer GmbH			1986-02-12
K860421	Strat Total Thyroxine Fluoromet Enzyme Immunoassay	American Dade	CDX	Class II	1986-02-11
K860419	Urea Nitrogen Reagent Set	Sterling Diagnostics, Inc.	CDW	Class II	1986-02-11
K860418	Creatinine Reagent Set	Sterling Diagnostics, Inc.	CGX	Class II	1986-02-11
K860351	Alkaline Phosphatase Reagent Set	Sterling Diagnostics, Inc.	CIO	Class II	1986-02-11
K860341	Total Protein (Biuret) Reagent Set	Sterling Diagnostics, Inc.	CEK	Class II	1986-02-11
K860285	Xro Gastro-Duodenal, Dual Flow Tube, Salem Type	Vygon Corp.	KNT	Class II	1986-02-11
K860252	Amerlex-M T3 Ria Kit for Serum and Plasma	Amersham Corp.	CDP	Class II	1986-02-11
K860251	Amerlex-M T4 Ria Kit for Serum and Plasma	Amersham Corp.	CEC	Class II	1986-02-11
K860225	Metricom	Far Orthopedics, Inc.	LDK	Unclassified	1986-02-11
K860215	Magnesium Reagent Set	Sterling Diagnostics, Inc.	JGJ	Class I	1986-02-11
K860213	Albumin Reagent Kit	Bio-Analytics Laboratories, Inc.	CIX	Class II	1986-02-11