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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2677 of 3530

510(k) clearances, page 2677 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K890212	Microsurgical Scissors	Kinetic Medical Products	HRR	Class I	1989-01-27
K890211	Microsurgical Needle Holders	Kinetic Medical Products	GDF	Class I	1989-01-27
K885254	Target Reader	V-Tech, Inc.	JQT	Class I	1989-01-27
K884977	Gas Trak Plus	United Diagnostics, Inc.	JJY	Class I	1989-01-27
K884807	Lipoclear Lipemia Clearing Reagent	Statspin Technologies	JKA	Class II	1989-01-27
K884751	Dansu Permanent Chair Soft Liner	American Mfg., Inc.	EBI	Class II	1989-01-27
K884702	Easy-Test Partial Thromboplastin Time Ptt #16629	Em Diagnostic Systems, Inc.	GFO	Class II	1989-01-27
K884700	Analyst Thyroxine (T4) Rotor	The du Pont Co.	KLI	Class II	1989-01-27
K884696	Resubmitted Artificial Insemination Instrument Set	Laboratoire Ccd C/O Washington Regulatory Services	HDR	Class II	1989-01-27
K884601	Technicon Systems Ra-100/Assist Chloride	Technicon Instruments Corp.	CHJ	Class II	1989-01-27
K884599	Technicon Ra-100 System Calcium Method	Technicon Instruments Corp.	CIC	Class II	1989-01-27
K884588	Heliomolar(r) Dental Restorative	Williams Dental Co., Inc.	EBF	Class II	1989-01-27
K884585	Lea Plaza Spinal Frame System	Orthomet, Inc.	KWP	Class II	1989-01-27
K883967	Beckman Liquid-Stat Magnesium Reagent & Standard	Beckman Instruments, Inc.	JGJ	Class I	1989-01-27
K880199	Cholinesterase - Acetythiocholine Substrate	Sclavo, Inc.	DIH	Class I	1989-01-27
K880049	Cholinesterase - Butyrythiocholine Substrate	Sclavo, Inc.	DIH	Class I	1989-01-27
K873496	Atypical Cholinesterase	Sclavo, Inc.	DIH	Class I	1989-01-27
K873200	Karlson Ozone Sterilizer Model 100B	Life Enhancement Technologies, LLC	FLF	Class II	1989-01-27
K871115	Ub Analyzer, Model Ua-1/Reagent Kit/bilirubin Con.	Labo Science-USA, Inc.	CIG	Class II	1989-01-27
K890174	Slt Clmd Contact Laser System (Addit. Indication)	Surgical Laser Technologies, Inc.	GEX	Class II	1989-01-26
K885149	Needle Insert for Soft Tissue Biopsy Device	Hart Enterprises, Inc.	DWO	Class I	1989-01-26
K884609	Euro-Collins Solution Sets	Fresenius USA, Inc.	KDL	Class II	1989-01-26
K884411	Optima Mpt and Spt Pacemakers	Telectronics, Inc.	DXY	Class III	1989-01-26
K882658	Angioscope for Pulmonary Artery Use	Washington Regulatory Services	DQO	Class II	1989-01-26
K885296	Miniflow Disposable Pressure Transducer 63-600F	Baxter Healthcare Corporation	DRS	Class II	1989-01-25
K885262	Polyhesive Monitoring and Diagnostic Electrodes	Medtronic, Inc.	DRX	Class II	1989-01-25
K885235	Safe-Draw(tm) Blood Sampling Reservoir & Access.	Spectramed, LLC	DSK	Class II	1989-01-25
K885019	Bemis Sterile-Case for Use W/ethylene Oxide Steri.	Bemis Health Care	FRG	Class II	1989-01-25
K883454	Mc6700 Multi-Channel Electrocardiograph	Cambridge Medical Instruments, Inc.	DPS	Class II	1989-01-25
K883359	Diagnostic Ultrasound System Ssa-270A	Toshiba Medical Systems	IYO	Class II	1989-01-25
K883037	Unilith 3 Models 7580/7583/7680/7683	Ela Medical, Inc.	DXY	Class III	1989-01-25
K882975	Re-Vent Arterial Blood Sampler And/or Biosampler	Richmann Laboratories	FMF	Class II	1989-01-25
K890148	Ats Tb Rapid Stain Set Product #034-45	Alpha-Tec Systems, Inc.	ICL	Class I	1989-01-24
K890119	Br-S601mu (Surgical Video Recorder)	Victor Co. of Japan, Ltd. C/O Jvc Corp.	FWC	Class I	1989-01-24
K890108	Modified Cushion-Flex(tm)	Life Design Systems, Inc.	BSJ	Class I	1989-01-24
K890103	Bard Tab ECG Monitoring Electrode	C.R. Bard Inc	DRX	Class II	1989-01-24
K890098	Kleen Test o.r. Kit	Kleen Test Products Corporation	LRO	Class II	1989-01-24
K890090	Danek Irrigating Burr (Dib) Set	Danek Medical, Inc.	GFF	Class I	1989-01-24
K890073	Modern Latex Sterile Surgical Gloves	Modern Rubber Co., Ltd. C/O World Trade Svc.	KGO	Class I	1989-01-24
K890071	Sterile Laceration Tray	Mumtaz I. Malik	LRP	Class I	1989-01-24
K890014	Disposable Color-Cuffs	Instrumed, Inc.	KCY	Class I	1989-01-24
K890006	Baxter Sterile Towel	Healthmed Corp.	KKX	Class II	1989-01-24
K890001	Double Antibody Serum Benzodiazepines	Siemens Healthcare Diagnostics Inc.	JXM	Class II	1989-01-24
K885275	Assenat-Bleschet Sunglasses	Roseburg SA	HQY	Class I	1989-01-24
K885142	Gauze Swabs, Non-Sterile	Smith & Nephew, Inc.	EFQ	Unclassified	1989-01-24
K885125	Krupin Eye Valve W/scleral Buckle	Hood Laboratories	KYF	Class II	1989-01-24
K885048	Access R-Clone Ana Profile Assay	Lipogen, Inc.	DHC	Class II	1989-01-24
K885030	Standard Administration Sets	3M Company	FPA	Class II	1989-01-24
K884844	Pleur-Evac(r) a-7002--Adult/pediatric Drainage	Deknatel, Inc.	CAC	Class II	1989-01-24
K884787	Acculite-Ppl 5	Medical Alignment Systems	INE	Class I	1989-01-24