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 1978 of 3531

510(k) clearances, page 1978 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K953805	0.9% Sodium Chloride Diluent in Plastic Syringe	Abbott Medical	FOZ	Class II	1996-06-28
K942227	Nicas 2001 Noninvasive Cardio-Respiratory System	C.L. Mcintosh & Assoc., Inc.	DSB	Class II	1996-06-28
K921968	In Vitro Diagnostic Reagent Set, Indir. Preg. Test	Tech-Co, Inc.	JHJ	Class II	1996-06-28
K915704	Amylase (Kinetic) Reagent Set	Tech Intl. Co.	CJD	Class II	1996-06-28
K961878	Sharps-Tainer	Winfield Industries	FMI	Class II	1996-06-27
K961840	Rusch Oral/nasal Tracheal Tube, Plain Magill/murphy	Rusch Intl.	BTR	Class II	1996-06-27
K961690	Cardioarc Series: Positioner C-Arm Models No. 6896.001 and 6896.105	Continental X-Ray Corp.	JAA	Class II	1996-06-27
K961516	Laser Peripherals Inc. Bare Fiber	Laser Peripherals LLC	GEX	Class II	1996-06-27
K961462	Cedia Theophylline Assay	Boehringer Mannheim Corp.	KLS	Class II	1996-06-27
K961404	Mx960 Reusable Pressure Transducer	Medex, Inc.	DRS	Class II	1996-06-27
K961310	Storz Premiere II Microsurgical System (Cx Series)	Storz Instrument Co.	HQC	Class II	1996-06-27
K961306	Deltatalker with Infrared	Prentke Romich Co.	IQA	Class II	1996-06-27
K961271	Usci Commander Series Guide Wires	C.R. Bard Inc	DQX	Class II	1996-06-27
K961267	Pioneer System Gtr(greater Trochanteer Reattachment) Device	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	JDQ	Class II	1996-06-27
K961251	Punctur-Guard Winged Set	Bio-Plexus, Inc.	FMI	Class II	1996-06-27
K961230	Easterclave	Easter Services, Inc.	FLE	Class II	1996-06-27
K960746	Sunmax Enterprise Shanghai Vinyl Powdered Patient Exam. Gloves	Sunmax Enterprise Shanghai Co., Ltd.	LYZ	Class I	1996-06-27
K960496	Liberty Lite Pfs System	Utah Medical Products, Inc	KPI	Class II	1996-06-27
K960478	Accumeter H. Pylori Test	Chemtrak, Inc.	LYR	Class I	1996-06-27
K960307	Index Shoe	Orthopedic Technology Research, Inc.	IRN	Class II	1996-06-27
K960173	Infra Vision Bougie Kit, Infra Vision Esophageal Kit	Gabriel Medical, Inc.	FAT	Class II	1996-06-27
K955918	Sinochem Ningbo Latex Examination Glove, Powder Free	Sinochem Ningbo Imp & Exp Corp.	LYY	Class I	1996-06-27
K955495	Rusch Reinforced Trachael Tube Cuffed, Sterile	Rusch, Inc.	BTR	Class II	1996-06-27
K953911	Philips Easyvision	Philips North America LLC	LLZ	Class II	1996-06-27
K953590	Comfit	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1996-06-27
K953339	Bonesource Hydroxyapatite Cement (Hac)	Osteogenics, Inc.	GXP	Class II	1996-06-27
K962297	Vivaglass Cem	Ivoclar North America, Inc.	EMA	Class II	1996-06-26
K962235	Vitros Specialty Diluent	Johnson & Johnson Clinical Diagnostics, Inc.	JJE	Class I	1996-06-26
K962165	Cobas-Fp Tdm Calibration Verification Test Set	Roche Diagnostic Systems, Inc.	DIF	Class I	1996-06-26
K962160	Mpm Hydrogel Dressing (Non-Sterile)	MPM Medical	MGQ	Unclassified	1996-06-26
K961995	Quicksplint	Kulzer GmbH	EBI	Class II	1996-06-26
K961910	Vivaglass Fil	Ivoclar North America, Inc.	EMA	Class II	1996-06-26
K961495	Huber Needle Extension Set with Standard Y-Injection Site, Interlink Y-Injection Site, Interlink T-Injection Site	Baxter Healthcare Corporation	FPA	Class II	1996-06-26
K961494	Series Xe 140Xe,40xe,10xe/series Se 140Se,40se,10se/series 10Te	Micro-Mega Societe Anonyme	EGS	Class I	1996-06-26
K961461	Daneshvar's Device (Modification)	Y. Daneshvar	DXC	Class II	1996-06-26
K961421	Synthes 2.4 Mm Universal Locking Plate System	Synthes (USA) Products LLC	JEY	Class II	1996-06-26
K961295	Sapphire Line Flat Drain/kit with Spi-Argent II W/or W/out Trocar	Sil-Med Corp.	GBX	Class I	1996-06-26
K961232	0.014 Floppy & 0.014 Intermediate Guide Wires W/phosphorylcholine Polymer Coating & 4Cm Radiopaque Tip	Biocompatibles, Ltd.	DQX	Class II	1996-06-26
K961222	Evron Gel	Pharmaceutical Innovations, Inc.	KMJ	Class I	1996-06-26
K961169	Rheumatoid Factor Latex Slide Test Kit	Randox Laboratories, Limited	DHR	Class II	1996-06-26
K954572	Maestro Clinical Remote Control	Respironics, Inc.	BZD	Class II	1996-06-26
K953741	Thermacyl Blood/fluid Warmer	Baxter Healthcare Corporation	BSB	Class II	1996-06-26
K942867	Clearwater Colon Hydrotherapy Model Ppc-101	Clearwater Colon Hydrotherapy, Inc.	KPL	Class II	1996-06-26
K962040	Rns Arthrogram Tray	Contour Fabricators of Florida, Inc.	FMI	Class II	1996-06-25
K962035	Ge Sterile Arthrogram Tray	GE Healthcare	FMI	Class II	1996-06-25
K961657	Ciba Corning 400 System	Ciba Corning Diagnostics Corp.	CHL	Class II	1996-06-25
K961390	Endopath Ets Linear/ets-Flex Articulating Linear Endoscopic Cutter	Ethicon Endo-Surgery Inc	OCW	Class II	1996-06-25
K961199	Bosworth Temporary Resin	Harry J. Bosworth Co.	EBG	Class II	1996-06-25
K955853	Healthcare Service & Supply Pump Alp 501 Pump System	Healthcare Service and Supply	JOW	Class II	1996-06-25
K953948	Spirovision Sv-III Pc Based Spirometer Kit Micro	Futuremed America, Inc.	BZG	Class II	1996-06-25