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 1797 of 3531

510(k) clearances, page 1797 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K982927	Quick Tap Self Drilling Screw	Kinamed Inc	DZL	Class II	1998-09-08
K982865	Atrisorb Bioabsorbable Guided Tissue Regeneration (Gtr) Barrier Kit	Atrix Laboratories, Inc.	NPK	Class II	1998-09-08
K982705	Midas Touch Bipolar Forceps	Iti Medical Technologies, Inc.	GEI	Class II	1998-09-08
K982665	Jumbo Silver-Reinforced Glass Ionomer	Centrix, Inc.	EMA	Class II	1998-09-08
K982616	Ips Empress 2	Ivoclar North America, Inc.	EIH	Class II	1998-09-08
K982494	Bwm Spine System	Howmedica Corp.	KWP	Class II	1998-09-08
K982445	Modulap	Atc Medical Technology, Inc.	GCJ	Class II	1998-09-08
K982439	Proxiderm, Models Tn 460, Tn 90 460, Bk 460	Progressive Surgical Products, Inc.	MKY	Class I	1998-09-08
K982401	Prostate Biopsy Needle	Remington Medical	KNW	Class II	1998-09-08
K982288	Radial Head Implant	Avanta Orthopaedics, Inc.	KWI	Class II	1998-09-08
K982258	Mammary Sizer	Specialty Surgical Products, Inc.	MRD	Unclassified	1998-09-08
K982234	Al-Gen Calcium Alginate Dressing	Innovative Technologies, Ltd.	KMF	Class I	1998-09-08
K982116	Aquacel Hydrofiber Wound Dressing	Convatec, A Bristol-Myers Squibb Co.	KMF	Class I	1998-09-08
K982055	Accuprobe 800 Series Model Numbers : 810, 820, 830, 840, 850, 860, 870 and 880	Cryomedical Sciences, Inc.	GEH	Class II	1998-09-08
K982042	Island Biosurgical Bladder Neck Bolstr Model Ibibol.002	Island Biosurgical, Inc.	OTN	Class II	1998-09-08
K982040	Medpor Surgical Granule Implants	Porex Surgical, Inc.	GXP	Class II	1998-09-08
K982031	Oculight Gl with the Dermatology Handpiece	Iridex Corporation	GEX	Class II	1998-09-08
K981095	Align System	Align Technology, Inc.	NXC	Class II	1998-09-08
K980457	Endo Absorbable Interference Screw	Endo Surgical Concepts, Inc.	HWC	Class II	1998-09-08
K974352	Cardioview 3000 Software	Micromedical, Inc.	LOS		1998-09-08
K982883	Medtronic 7F and 8F Zuma Guiding Catheter	Medtronics Interventional Vascular	DQY	Class II	1998-09-04
K982841	Modification to Alliger Ultrasonic Surgical System, Model Auss-4	Misonix, LLC	LFL	Unclassified	1998-09-04
K982672	Colleague Pump Syringe Adapter Set	Baxter Healthcare Corporation	FPA	Class II	1998-09-04
K982595	Nim4	Xomed, Inc.	ETN	Class II	1998-09-04
K982339	Flow 7000 Peripheral Vascular Coil	GE Healthcare Coils	MOS	Class II	1998-09-04
K982117	Fluid Control	T.A. Coleman Ent.	EIA	Class I	1998-09-04
K982102	Singleday Infusor 2 Ml/hr (Elastomeric Infusion Device) Model, Infusor Sv 5 Ml/hr (Elastomeric Infusion Device) Model Cy	Baxter Healthcare Corporation	MEB	Class II	1998-09-04
K982088	Affirm Smart Releasable Force Module and Compliance Science System	Ortho Kinetics Corp.	DZB	Class II	1998-09-04
K982025	Hewlett-Packard M2475b with 12-Lead Option (#C90) Codemaster 100 Conitor/defibrillator	Hewlett-Packard Co.	MKJ	Class III	1998-09-04
K982023	Pelicalss Human Igg Subclass Nephlometric Array Kit	Inova Diagnostics, Inc.	DAS	Class I	1998-09-04
K982014	Stockert Compact System	Stoeckert Instrumente	DTQ	Class II	1998-09-04
K981999	Albatech Personal Monitor	Albatech, Inc.	GCJ	Class II	1998-09-04
K981314	Visualine II (Also Known as Sunline) Methadone	Sun Biomedical Laboratories, Inc.	DJR	Class II	1998-09-04
K981009	Heartport Endopulmonary Vent Catheter	Heartport, Inc.	DWF	Class II	1998-09-04
K980642	Evita 4 (8411900)	Drager, Inc.	CBK	Class II	1998-09-04
K980630	Frialit-2 Corabase	Friatec AG	DZE	Class II	1998-09-04
K973477	Biosensors Embolectomy Catheter	Sunscope Intl., Inc.	DXE	Class II	1998-09-04
K982709	Modification to Prospect Cryptosporidium Microtiter Assay	Alexon - Trend, Inc.	MHJ	Class II	1998-09-03
K982491	Sangui Biotech, Inc. Calcitonin Elisa Kit	Sangui Biotech, Inc.	JKR	Class II	1998-09-03
K982089	Accu-Chek Advantage Test Strips and Accu-Chek Advantage H Test Strips	Boehringer Mannheim Corp.	LFR	Class II	1998-09-03
K981994	Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter	C.R. Bard Inc	MSD	Class II	1998-09-03
K981981	Electrosurgical Unit (Esu) (115 Volt) Model 4810, Electrosurgical Unit (Esu) (230 Volt) Model 4811, Instrument Cable, 19	Boston Scientific Corporation	GEI	Class II	1998-09-03
K981973	Safe-T-Fill Capillary Blood Collection System	Ram Scientific	JKA	Class II	1998-09-03
K981929	Bindazyme Antigliadin Igg/iga Combi Kit	The Binding Site	MST	Class II	1998-09-03
K981644	Bindazyme Antigliadin Igg	The Binding Site	MST	Class II	1998-09-03
K981639	System U3 for Ciprofloxacin	Ab Biodisk	JWY	Class II	1998-09-03
K980883	N-Assay Glu-Ul	Crestat Diagnostics, Inc.	CFR	Class II	1998-09-03
K982774	Soft (Hydrophilic) Contact Lenses	Cl-Tinters	LPL	Class II	1998-09-02
K982706	Philips Bv300 Series Release 2.1	Philips North America LLC	OXO	Class II	1998-09-02
K982645	Pyramid	Bisco Inc	EBF	Class II	1998-09-02