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 2145 of 3531

510(k) clearances, page 2145 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940534	Gyroscan T10-Nt (Release 4 Series Software)	Philips North America LLC	LNH	Class II	1994-11-22
K940287	Meniscal Suture Instrumentarium	Richard Wolf Medical Instruments Corp.	HRX	Class II	1994-11-22
K940016	Electric Surgical Drill	Alamo City Dental Supply Co.	ERL	Class II	1994-11-22
K935702	Dade Innovin II	Baxter Diagnostics, Inc.	GJS	Class II	1994-11-22
K935494	Daneshvar's Device	Y. Daneshvar	DXC	Class II	1994-11-22
K935307	Dade(r) Thrombin-Antithrombin (Tat) Complex Elisa	Baxter Diagnostics, Inc.	DDQ	Class II	1994-11-22
K935249	Advanced Magmag Ac/battery Breast Pump	Pigeon Corp.	HGX	Class II	1994-11-22
K934505	Trigel Multifunction Electrode	Physiometrix, Inc.	DRX	Class II	1994-11-22
K934003	Stratus Digoxin Flourometric Enzyme Immunoassay	Baxter Diagnostics, Inc.	DKA	Class II	1994-11-22
K933414	Stratus(r) Thyroid Uptake Fluor Enzyme Immunoassay	Baxter Diagnostics, Inc.	KHQ	Class II	1994-11-22
K933360	Gluma 3 Step Bonding System/ Gluma 3 Primer/desensitizer	Miles Inc., Dental Products	KLE	Class II	1994-11-22
K923395	Vident Impac Implant Accessories	Vident	DZE	Class II	1994-11-22
K945083	Access Ck-Mb Reagents	Bio-Rad Laboratories Inc.	JHS	Class II	1994-11-21
K944701	Calibrators	Diagnostic Reagents, Inc.	JIS	Class II	1994-11-21
K944505	Diastat Ena Single Well Screen Kit	Shield Diagnostics, Ltd.	LLL	Class II	1994-11-21
K944253	Monoclonal Mouse Anti-Human T-Cell, Cd8, Rpe-Conjugated, Clone Dk25	Dako Corp.	GKZ	Class II	1994-11-21
K944096	Hep-2000 Fluorescent Ana-Ro Test System	IMMUNO CONCEPTS, NA, Ltd.	DHN	Class II	1994-11-21
K944088	Cx(tm) Cannabinoid 100 Ng(thc) Reagent/synchron Cx Sys	Beckman Instruments, Inc.	LDJ	Class II	1994-11-21
K944076	Cx(tm) Benzodiazepine(benz) Reagent for Sychron Cx Sys	Beckman Instruments, Inc.	JXM	Class II	1994-11-21
K943836	Pre-Filled 10Cc Inflation Syringe W/sterile Water	Orion Life Systems, Inc.	JOL	Class II	1994-11-21
K943834	Sterile .9% Sodium Chloride Solution	Orion Life Systems, Inc.	JOL	Class II	1994-11-21
K943832	Sterile .9% Sodium Chloride for Irration	Orion Life Systems, Inc.	JOL	Class II	1994-11-21
K943831	Pre-Filled 30Cc Inflation Syringe W/sterile Water	Orion Life Systems, Inc.	JOL	Class II	1994-11-21
K943830	Pre-Filled Syringe W/sterile 0.9% Sodium Chloride Solution	Orion Life Systems, Inc.	JOL	Class II	1994-11-21
K943829	Pre-Filled Sysringe W/sterile Water	Orion Life Systems, Inc.	JOL	Class II	1994-11-21
K943828	Sterile Water for Irrigation	Orion Life Systems, Inc.	JOL	Class II	1994-11-21
K943676	Danekscope Opti-Probe	Danek Medical, Inc.	HRX	Class II	1994-11-21
K943284	Monoclonal Mouse Anti-Human B-Cell	Dako Corp.	GKZ	Class II	1994-11-21
K942958	Creatine Kinase Mb Determination (UV)	Biochemical Trade, Inc.	JHW	Class II	1994-11-21
K941971	9100 Mutigas Monitor	Bci Intl., Inc.	CCK	Class II	1994-11-21
K941872	Specialty Assayed Control-2 Cat. No. 5302	Helena Laboratories, Corp.	GGC	Class II	1994-11-21
K941247	Vident Impac Infinite Position Abutment	Vident	DZE	Class II	1994-11-21
K940998	Impac Torque Wrench	Vident	DZE	Class II	1994-11-21
K940812	Insight Electronic Alignment Indicator	Andronic Devices, Ltd.	KQX	Class I	1994-11-21
K940375	Micro Mpm	Micro Direct, Inc.	CAP	Class II	1994-11-21
K924804	Dako Mouse Anti-Human T-Cell	Dako Corp.	DEH	Class II	1994-11-21
K945314	Cleveland Tubing, Inc. Expandable/collapsiblemedical Tubing	Cleveland Tubing, Inc.	CAI	Class I	1994-11-18
K944651	Dried Gram-Positive Mic/combo Panels	Baxter Diagnostics, Inc.	JWY	Class II	1994-11-18
K944476	Apex Universal Drive System	Linvatec Corporation	ERL	Class II	1994-11-18
K944429	Precision Thermoplastic Componenets, Inc. Tubing	Precision Thermoplastic Components, Inc.	CAI	Class I	1994-11-18
K944311	Acra-Cut	Acra Cut, Inc.	HBO	Class II	1994-11-18
K944152	Pari Baby	Pari Holding Co.	CAF	Class II	1994-11-18
K943721	Otoview Telescopic Otoscopes	Smith & Nephew, Inc.	ERA	Class I	1994-11-18
K942512	Pa300	The Rival Co.	FRF	Class II	1994-11-18
K940807	See-Thru Self Sealing Sterilization Pouch	Asep-Pro, Inc.	KCT	Class II	1994-11-18
K925849	Zest Implant Anchor	Zest Anchors LLC	DZE	Class II	1994-11-18
K925610	Flexible Hydroxylapatite/silicone Soft Chin Implan	Microtek Medical LLC	FWP	Class II	1994-11-18
K945000	Multidex Hydrophilic Wound Dressing	Lange Medical Products, Inc.	KMF	Class I	1994-11-17
K944948	Free-Lance	F.F.F. Enterprises, Inc.	FMK	Class II	1994-11-17
K944891	Sas Quant Hcg Urine	SA Scientific, Ltd	JJX	Class I	1994-11-17