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 2026-10-26, 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 2782 of 3530

510(k) clearances, page 2782 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K873266	Middlebrook Based Media	Central Media	KZI	Class I	1987-10-28
K873265	Media for Anaerobic/microaerphilic Isolation	Central Media	JSI	Class I	1987-10-28
K873264	Media for Detection & Verification of Coliforms	Central Media	JSI	Class I	1987-10-28
K873263	Maintenance & Carbohydrate Fermentation Media	Central Media	JSH	Class I	1987-10-28
K873262	Differential Media	Central Media	JSI	Class I	1987-10-28
K873261	Enteric Isolation Media	Central Media	JSI	Class I	1987-10-28
K872986	Model 28200C/shoulder/ankle/elbow/hip/tmj/sm Joint	Karl Storz Endoscopy-America, Inc.	HRX	Class II	1987-10-28
K872379	Insall/burstein* II Modular Total Knee	Zimmer GmbH	JWH	Class II	1987-10-28
K872120	Seralyzer III Blood Chemistry Analyzer	Miles Laboratories, Inc.	JJF	Class I	1987-10-28
K871878	Rapid Diagnostic System for Chlamydia Trachomatis	Hologic, Inc.	LSK	Class I	1987-10-28
K870922	C.l.e. Acetabular Cup	Protek, Inc.	JDI	Class II	1987-10-28
K870662	Model Skck Sterile Knob Cover Kit	Life-Tech Intl., Inc.	BXM	Class II	1987-10-28
K873953	Cm 5000R Remote Airway Pressure	Canadian Monaghan, Ltd.	CAP	Class II	1987-10-27
K873878	#24L System	Pentron Corp.	EBF	Class II	1987-10-27
K873671	Coltene President Jet Impression Materials System	Coltene, Inc.	EKS	Class I	1987-10-27
K873644	Pulp Pen	The Hygenic Company, LLC	EAT	Class II	1987-10-27
K873441	Baker Twin-Cuff Intestinal Decomp/plication Tube	Bissell Medical Products, Inc.	KNT	Class II	1987-10-27
K873373	Sinterloy	Denpac Corp.	EJS	Class II	1987-10-27
K873213	Hickman Plastic Subcutaneous Port	C.R. Bard Inc	LJT	Class II	1987-10-27
K873146	Usi Basic. Ag 1050. Ag 1090	Cranston Ind., Inc.	ELC	Class II	1987-10-27
K871884	In the Ear & in the Canal Hearing Aid Face Plate	Hearing Services, Inc.	LRB	Class I	1987-10-27
K871731	Telstar Prewire Series	Telstar Electronics, Inc.	LRS	Class II	1987-10-27
K873690	Cedar(tm) Pelvic Cushion	Cedar Surgical, Inc.	LWG	Class I	1987-10-26
K873689	Cranioplastic, Acrylic Cranioplasty Material	Dentsply Intl.	GXP	Class II	1987-10-26
K873688	Aneuroplastic, Acrylic Aneuryomorrhaply Material	Dentsply Intl.	JXH	Class II	1987-10-26
K873595	Surgical Pencil/ Electrosurgical Pencil	Yuntek International, Inc.	GEI	Class II	1987-10-26
K873584	Modified Q4000 & Q3040 Electrocardiograph Monitor	Quinton, Inc.	DPS	Class II	1987-10-26
K873544	Mpg-50 X-Ray Generator	Thomson-Cgr Medical Corp.	IZO	Class I	1987-10-26
K873535	Nicolet Expert Sleep/wake Analysis System	Nicolet Biomedical Instruments	GWQ	Class II	1987-10-26
K873357	Electrobloc Trans. Electrical Nerve Block Genera.	Th Charters, Inc.	GZJ	Class II	1987-10-26
K873286	Disposable, Manual Pulmonary Resuscitator	Hospitak, Inc.	BTM	Class II	1987-10-26
K873155	Gambro Bicart System	Gambro, Inc.	FKP	Class II	1987-10-26
K873065	Model 7200A with Pulse Oximetry	Medtronic, Inc.	DQA	Class II	1987-10-26
K872631	Infant Monitor, Model 2400	Arvee Medical, Inc.	BZQ	Class II	1987-10-26
K872132	Sophy Series of Nuclear Medicine Computer Systems	Sopha Medical Systems, Inc.	IXY	Class I	1987-10-26
K870028	Smk Sluyter-Mehta Cannulae, RF Pole, Pole,flexible	Radionics, Inc.	GXI	Class II	1987-10-26
K874034	Adr-22 Automatic Dialyzer Reprocessor	Biodynamics Corp.	LIF	Class II	1987-10-23
K873975	Phenylethyl Alcohol Agar(pea) W/5% Sheep #P3323	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-10-23
K873957	Non-Coring Huber Type Needles	Advantage Medical Systems, Inc.	FMI	Class II	1987-10-23
K873952	Micro Culture Media P3141, P3136, P3148, P3748	Lakewood Biochemical Co., Inc.	KZI	Class I	1987-10-23
K873951	Micro Culture Media P3528, P3137, P3149, P3139	Lakewood Biochemical Co., Inc.	JSJ	Class I	1987-10-23
K873928	Universal Tourniquet	Dryden Corp.	GAX	Class I	1987-10-23
K873876	Pharmacia Deltec Bag Spike Set	Pharmacia Deltec, Inc.	FPA	Class II	1987-10-23
K873848	Retrobulbar Needle	Healthtek, Inc.	GDM	Class I	1987-10-23
K873830	Tecnol Surgeon's Cap	Tecnol New Jersey Wound Care, Inc.	FYF	Class I	1987-10-23
K873786	Smith & Nephew Daylighter(tm)	Smith & Nephew, Inc.	FSY	Class II	1987-10-23
K873588	10Cc Control Syringe	Medi-Plast Intl., Inc.	FMF	Class II	1987-10-23
K873555	Gorsk Sponge Containment System	Gorsk, Inc.	LWH	Class I	1987-10-23
K873554	Gorsk Instrument Rest	Gorsk, Inc.	HMG	Class I	1987-10-23
K873487	Hd-400-A/b/c Hemodialysis Systems & Accessories	Water Pure, Inc.	FIP	Class II	1987-10-23