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 1813 of 3531

510(k) clearances, page 1813 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K973864	Combi Elevator-2 & Combi Elevator-2 Tomo	Pausch Corp.	IZF	Class II	1998-06-17
K981759	Phos	Abbott Medical	CEO	Class I	1998-06-16
K981754	Automatic Vacuum Switch (Avs) Model Number Avs 5000	Precision Fluidics Division Parker Hannifin Corp.	CBN	Class II	1998-06-16
K981578	Ca	Abbott Medical	CJY	Class II	1998-06-16
K981514	Gc Fuji Bond Lc	GC America Inc.	KLE	Class II	1998-06-16
K981448	Kerr Hard Denture Reline Material	Sybron Dental Specialties, Inc.	EBI	Class II	1998-06-16
K981383	Alloybond	Southern Dental Industries, Inc.	KLE	Class II	1998-06-16
K981202	Water Filled Gum Soother	Corium Corp.	KKO	Class II	1998-06-16
K981197	One Step Urine Drug of Abuse Amphetamine Test	Tcpi, Inc.	DKZ	Class II	1998-06-16
K981193	Innovasive 3.5Mm Metal Roc Xs Suture Bone Fastener	Innovasive Devices, Inc.	MBI	Class II	1998-06-16
K981157	Stable Flow	Cmed	FPA	Class II	1998-06-16
K981046	Medtronic Ps Medical External Drainage and Monitoring (Edm) Ventricular Catheter, 20Cm and 35 Cm Model # 96115 and 96118	Medtronic PS Medical	JXG	Class II	1998-06-16
K981015	Pali-Trode	Preferred Instruments	GZL	Class II	1998-06-16
K981003	Rockwell Medical Supply, Llc. Dri-Sate Acid Concentrate Mixes	International Medical Products, Inc.	KPO	Class II	1998-06-16
K980738	Psi-Tec Syringe Infusion Pump and Accessories for General Fluid Irrigaion/infiltration	Byron Medical	FRN	Class II	1998-06-16
K980216	Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6	Kreativ, Inc.	KOJ	Class II	1998-06-16
K980144	Heartview P12/8 Electrocardiograph Recorder and Transmitter	Aerotel Ltd.	DXH	Class II	1998-06-16
K974761	Butler Antibacterial Interdental Toothbrush	John O. Butler Co.	EFW	Class I	1998-06-16
K981752	I-Stat Coagulation Control Set	Biopool Intl., Inc.	GGN	Class II	1998-06-15
K981632	Roche Diagnostics, Boehringer Mannheim Liquid Total Bilirubin Reagent	Roche Diagnostics/Boehringer Mannheim GmbH	CIG	Class II	1998-06-15
K981496	Color-Slide RF	Seradyn, Inc.	DHR	Class II	1998-06-15
K981439	Cca-200	Benson Medical Instruments Co.	EWO	Class II	1998-06-15
K981233	Ksea Calcusplit	Karl Storz Endoscopy-America, Inc.	FFK	Class II	1998-06-15
K980980	Motility Probe Model Numbers P31 Thru P38, P40 Thru P43 and P50	Konigsberg Instruments, Inc.	FFX	Class II	1998-06-15
K980639	Seraquest Anti-Ssb	Quest Intl., Inc.	LLL	Class II	1998-06-15
K980540	Seraquest Anti-Sm	Quest Intl., Inc.	LKP	Class II	1998-06-15
K980335	Etest Benzylpenicillin	Ab Biodisk	JWY	Class II	1998-06-15
K974087	Model M1792a Thrombolytic Predictive Instrument	Hewlett-Packard Co.	LOS		1998-06-15
K973365	Aic - Chek (Hbaic-I)	Express-Med, Inc.	LCP	Class II	1998-06-15
K981864	Access Afp Qc on the Access Immunoassay Analyzer, Model Number 33219	Siemens Healthcare Diagnostics Inc.	JJX	Class I	1998-06-12
K981797	B-D Pen Ultra	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1998-06-12
K981795	Cleaning Solution (1) Model Number A943-795, Salt Bridge Solution Model Number A943-794, Calibration Solution, Ph 7.4 Mo	Thermo Bioanalysis Corp.	JIX	Class II	1998-06-12
K981771	Accusign Mop, Biosign Mop, Staus Ds Mop	Princeton BioMeditech Corp.	DJG	Class II	1998-06-12
K981758	Albg	Abbott Medical	CIX	Class II	1998-06-12
K981638	Immage Immunochemistry System C-Reactive Protein (Crp) Reagent	Siemens Healthcare Diagnostics Inc.	DCK	Class II	1998-06-12
K981118	Phos	Abbott Medical	CEO	Class I	1998-06-12
K981056	Varian Ximatron Scan Vision CT	Varian Medical Systems, Inc.	KPR	Class II	1998-06-12
K980979	Fukuda Denshi Model Hc-500 End Tidal CO2 Module	Fukuda Denshi USA, Inc.	CCK	Class II	1998-06-12
K980972	Rigid Culdoscope and Accessories	Circon Corp.	HEW	Class II	1998-06-12
K980569	Fracture Risk Assessment Capability for Norland X-Ray Bone Densitometers	Norland Corp.	KGI	Class II	1998-06-12
K980289	Fracture Risk Assessment for the Norland Sxa 3000 Bone Densitometer	Norland Corp.	KGI	Class II	1998-06-12
K980074	56 Series Aerosol Generator	Project Marketing	CAF	Class II	1998-06-12
K974769	Cosgrove Clamp	Medtronic, Inc.	DXC	Class II	1998-06-12
K973975	Respirtechpro	Vortran Medical Technology 1, Inc	BTL	Class II	1998-06-12
K973096	Neotonus Model 1000 Muscle Stimulator System	Neotonus, Inc.	KPI	Class II	1998-06-12
K981767	Qtexx Powderfree Latex Examination Gloves	Latexx Partners Bhd.	LYY	Class I	1998-06-11
K981580	Hdl	Abbott Medical	LBS	Class I	1998-06-11
K981390	Odontosurge 2	Periogiene	EKZ	Class II	1998-06-11
K981325	3M M.g. Material	3M Company	ELW	Class II	1998-06-11
K980987	Becton Dickinson Syringe	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1998-06-11