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 2016 of 3531

510(k) clearances, page 2016 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K955357	Olympic Smart Scale Model 50/50Ra	Olympic Medical Corp.	FRW	Class I	1996-01-30
K955271	Micro-Seal Acetabular System	Whiteside Instruments	LPH	Class II	1996-01-30
K955268	Pq-2000+ Computed Tomography X-Ray System	Philips North America LLC	JAK	Class II	1996-01-30
K955261	Neutralect Adult Standard, Return (Rem) & Paediatric Electrosurgery Plate (Modification)	Msb, Ltd.	GEI	Class II	1996-01-30
K955116	Benzodiazepines by Remedi Hs	Bio-Rad	LAA	Class II	1996-01-30
K955018	Trip Ngs & Sigmoid Catheter Phi Slide Calculator	Instrumentarium Corp.	FFT	Class I	1996-01-30
K955016	4C Plus Coulter Cell Control	Coulter Corp.	JPK	Class II	1996-01-30
K955008	Heat & Moisture Exchanger	Intertech Resources, Inc.	BYD	Class I	1996-01-30
K954926	Hm-Cap Control Panel	E-Z-EM, Inc	LYR	Class I	1996-01-30
K954866	Mercury CPR (Complete Personal Resusciator) Bag with Expandable Reservoir	Mercury Medical	BTM	Class II	1996-01-30
K954823	Venipuncture Kit	Winfield Industries	FPA	Class II	1996-01-30
K954784	Dryside Neisseria	Difco Laboratories, Inc.	LTS	Class I	1996-01-30
K954483	Stryker Sagittal Saw Attachment	Stryker Corp.	GFA	Class I	1996-01-30
K954437	Thrombelastograph Coagulation Analyzer 3000S	Haemoscope Corp.	GKP	Class II	1996-01-30
K953439	Ultrack Total Knee System	Wrightmedicaltechnologyinc	JWH	Class II	1996-01-30
K953350	Mli Interference Screw	Medicinelodge, Inc.	HWC	Class II	1996-01-30
K953341	Aria CPAP System	Respironics, Inc.	BZD	Class II	1996-01-30
K952837	Darwin Hypodermic Safety System (Dhss)	Emk Enterprises, LLC	FMI	Class II	1996-01-30
K952666	Chrom Z-Protein C, Cat. No. 5243	Helena Laboratories, Corp.	GGP	Class II	1996-01-30
K952249	Jet Nebulizer	Devilbiss Health Care, Inc.	CAF	Class II	1996-01-30
K951550	Cmv Brite Antigenemia Test Kit	Biotest Diagnostics Corp.	LIN	Class II	1996-01-30
K946070	Human Beta-2 Microglobulin Turbindimetric Kit	The Binding Site	JZG	Class II	1996-01-30
K946069	Human Beta-2 Microglobulin Enhanced Nephelometric Kit	The Binding Site	JZG	Class II	1996-01-30
K946068	Human Beta-2 Microglobulin Enhanced Radial Immunodiffusion Kit	The Binding Site	JZG	Class II	1996-01-30
K943803	Jostra Hl-20 Integrated Perfusion System	Janus Biomedical, Inc.	DTQ	Class II	1996-01-30
K941993	Pharmacia Cap System Phadiatop Feia	Pharmacia, Inc.	DHB	Class II	1996-01-30
K940744	Sofamor, Laurain Dewald Anterior Fixation	Sofamor Co.	KWQ	Class II	1996-01-30
K955695	Plastic Frame, Metal Frame, Optical	Dah Sing Trading Co.	HQY	Class I	1996-01-29
K955441	Zong Rong Sunglasses	Zong Rong Glasses Ltd. Co.	HQY	Class I	1996-01-29
K955438	Urine Reagent Strips-3 Parameters (Modification)	Teco Diagnostics	JIR	Class I	1996-01-29
K955434	Access Folate Assay (Modification)	Siemens Healthcare Diagnostics Inc.	CGN	Class II	1996-01-29
K955335	Disposable Hypodermic Monopolar Needle Recording Electrode	Chalgren Enterprises, Inc.	IKT	Class II	1996-01-29
K955287	Zong Rong Sunglasses	Yuu Yeng Enterprise Co., Ltd.	HQY	Class I	1996-01-29
K954998	Lily Dark Viewer	Lily Imaging Solutions Co.	IXC	Class I	1996-01-29
K954945	Hanel Mavig Monitor Suspension System	F. Walter Hanel GmbH	JAA	Class II	1996-01-29
K954729	Pen-Inject 2.25	Scandinavian Health Ltd.	KZH	Class II	1996-01-29
K954002	Ampri	Ampri Rubberware Industries Sdn Bhd	KGO	Class I	1996-01-29
K952984	Map Multitrack Angiographic Catheter (4F)	Map Medical Equipment, Inc.	DQO	Class II	1996-01-29
K952941	Sun Model Oa 3000 Oxygen Analyzer	Sun Medical Equipment, Inc.	CAW	Class II	1996-01-29
K952694	Co Breath Analysis Module & Monoxol II	Bacharach, Inc.	CCJ	Class II	1996-01-29
K945256	Mtc 7707 High Speed Air Turbine	Mtc Industries and Research, Ltd.	EFB	Class I	1996-01-29
K944436	Cobe Centrysystem Cs 200 Dialyzer	Cobe Renal Care, Inc.	FJI	Class II	1996-01-29
K943366	Il Test Acid Phosphatase	Instrumentation Laboratory Co.	CKB	Class II	1996-01-29
K936312	Manual Massage Roller	Mckenna & Cuneo	LYG	Class I	1996-01-29
K955861	Microquartz Medical Type B Side-Firing Laser Fiber	Microquartz Medical, Inc.	GEX	Class II	1996-01-26
K955751	Prime Femoral Cement Plug	Orthopaedic Innovations, Inc.	LZN	Class II	1996-01-26
K955433	Duralastic Silicone Tubing	Allied Biomedical Corp.	KGZ	Class I	1996-01-26
K955320	Protec Cotton Padding Bandage	Derivadas Degasa S.A. de C.V.	LGF	Class I	1996-01-26
K955254	Shimadzu Whole Body X-Ray CT Scanner Sct-7000Tc	Shimadzu Medical Systems	JAK	Class II	1996-01-26
K955253	Shimadzu Whole Body X-Ray Scanner Sct-7000Th	Shimadzu Medical Systems	JAK	Class II	1996-01-26