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 1953 of 3531

510(k) clearances, page 1953 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K963685	Eos Brand Disposable Cyto/cervical Sampler	North Eos Industries, Inc.	HHT	Class II	1996-10-11
K963652	Pulpdent Desensitizer	Pulpdent Corporation	EBF	Class II	1996-10-11
K963538	Sigma Diagnostics Co2alkaline Buffer	Sigma Diagnostics, Inc.	JFL	Class II	1996-10-11
K963461	Safety Poncho/shoulder Strap Poncho	Skil-Care Corp.	KID	Class I	1996-10-11
K963365	Multi-Purpose Medical Tube Holder	Byrd Medical Devices, Inc.	KMK	Class I	1996-10-11
K963332	Thermo-Plastic Shaver Blades	Stryker Corp.	HRX	Class II	1996-10-11
K963294	Heelbo Wrap Around Vest	Heelbo, Inc.	FMQ	Class I	1996-10-11
K963141	Kugel Hernia Patch	Douglas Bueschel	FTL	Class II	1996-10-11
K963050	Tradition P, Push Button Handpiece	Midwest Dental Products Corp.	EFB	Class I	1996-10-11
K963032	Free Choice	First Quality Hygienic, Inc.	HEB	Class II	1996-10-11
K962972	Surgicade Gauze Sponge	Accunex Canada,Inc.	EFQ	Unclassified	1996-10-11
K962905	Tx Biopsy Needle	Gallini S.r.l.	FCG	Class II	1996-10-11
K962799	Miniature Laparoscope Set (Mini Lap)	Richard Wolf GmbH	GCJ	Class II	1996-10-11
K962761	Reigel Tunneling Device	Cook Inc.	GYK	Class I	1996-10-11
K962746	Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit	Cordis US Corp.	DYB	Class II	1996-10-11
K962733	Cyber-Fil Alkenoate Cement Multi-Purpose Kit (23900/23905/23910/23915/23920)	Union Broach, Div. Moyco Industries, Inc.	EMA	Class II	1996-10-11
K962394	Implant Integration Systems Drills and Taps	Implant Integration Systems, Inc.	DZE	Class II	1996-10-11
K962149	Safety Cradle	Specialized Health Products, Inc.	FMI	Class II	1996-10-11
K962078	Tracheostomy Cleaning Tray W/suction Catheter	Continental Medical Laboratories, Inc.	JOH	Class II	1996-10-11
K961423	Osom Strep a Test	Wyntek Diagnostics, Inc.	GTZ	Class I	1996-10-11
K961368	Trimflo Parenchymal Blood Flow Monitoring Probe Kit	Vasamedics, LLC	DPT	Class II	1996-10-11
K961166	Flowtron Excel Pump	Hne Healthcare, Inc.	JOW	Class II	1996-10-11
K955712	Usci Bipolar Balloon Pacing Electrode with Bh Coating	C.R. Bard Inc	LDF	Class II	1996-10-11
K954416	Polymer Coated Powder-Free Latex Examination Gloves	Hartalega Sdn Bhd	LYY	Class I	1996-10-11
K953213	Comfit (Powder Free Examination Gloves (Hypoallergenic, Low Protein, Beaded)	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1996-10-11
K963752	Partial & Total Ossicular Replacement Prosthesis	Grace Medical, Inc.	ETB	Class II	1996-10-10
K963536	Sigma Diagnostics Calicium Reagent	Sigma Diagnostics, Inc.	CJY	Class II	1996-10-10
K963398	Alta Fully Threaded Cross-Locking Screws	Howmedica Corp.	HWC	Class II	1996-10-10
K963390	Biopsy Introducer Needle	Baxter Healthcare Corporation	KNW	Class II	1996-10-10
K963220	Tempra Cold Pack, Reorder No. Tc150	Tempo Technology, Inc.	IMD	Class I	1996-10-10
K963180	Vidamed RF Generator Data Recorder	Vidamed, Inc.	GEI	Class II	1996-10-10
K963118	Extremity Bone Screw	Acu Med, Inc.	HWC	Class II	1996-10-10
K963056	Ed-3410, Video Duodenoscope	Pentax Precision Instrument Corp.	FDT	Class II	1996-10-10
K962962	Deodorant Panty Liner	Paragon Trade Brands, Inc.	HHL	Class II	1996-10-10
K962954	Deodorant Maxi Pad	Paragon Trade Brands, Inc.	HHL	Class II	1996-10-10
K962953	Deodorant Panty Shield	Paragon Trade Brands, Inc.	HHL	Class II	1996-10-10
K962926	Orgentec Anti-Cardiolipin Screen Elisa Assay	American Laboratory Products Company	MID	Class II	1996-10-10
K962766	Airsep Impulse	Airsep Corp.	NFB	Class II	1996-10-10
K962759	4F Nylex Angiographic Catheter	Cordis US Corp.	DQO	Class II	1996-10-10
K962749	Therapep W/mouthpiece, W/pediatric Mask, W/small Mask, W/large Mask, Resistor/port/mouthpiece, Resistor/port	Diemolding Corp.	BWF	Class II	1996-10-10
K962738	Millennium Mt and Millennium Mg Nuclear Medicine Systems	GE Healthcare	KPS	Class II	1996-10-10
K962127	Ohmeda 3800 Pulse Oximeter	GE Healthcare	DQA	Class II	1996-10-10
K961929	Factor Deficient Plasma	Universal Reagents, Inc.	GGP	Class II	1996-10-10
K961889	Specific Allergen Modules and Mixed Allergen Panels for Alastat Microplate and Alastat Eia Allergen-Specific Ige Systems	Siemens Healthcare Diagnostics Inc.	DHB	Class II	1996-10-10
K961228	Karl Storz Magnifying Arthrosocpes	Karl Storz Endoscopy-America, Inc.	HRX	Class II	1996-10-10
K961165	Hp M2600a Omnicare Telemetry System Model M2600a	Hewlett-Packard Co.	DSI	Class II	1996-10-10
K960710	Condom	Polar Latex, Ltd.	HIS	Class II	1996-10-10
K960515	Parapac	Pneupac, Ltd.	BTL	Class II	1996-10-10
K955137	Im C-Ment Acetabular Cap	Implant Ideas, LLC	JDI	Class II	1996-10-10
K954481	P.f.c. Uni-Compartmental Knee System	Johnson & Johnson Professionals, Inc.	HRY	Class II	1996-10-10