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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3459 of 3526

510(k) clearances, page 3459 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K780039	Aspartate Transaminase	Beckman Instruments, Inc.	CIT	Class II	1978-01-31
K780002	Antithrombin III Assay	Ortho Diagnostics, Inc.	JBQ	Class II	1978-01-31
K772354	i.v. Catheter	Ndm Corp.	FOZ	Class II	1978-01-31
K772352	Stac System - Additional Analytes	Technicon Instruments Corp.	CGS	Class II	1978-01-31
K772344	Data Acquisition & Collating Sys.	Gilford Instrument Laboratories, Inc.	JJE	Class I	1978-01-31
K780115	Scanners, Tomographic, Computed	Ohio Nuclear, Inc.	JAK	Class II	1978-01-30
K780112	Spectrophotometer, Model 5000	Revvity Health Sciences, Inc.	JXR	Class I	1978-01-30
K780107	Analyzer-Plug-in, CO2 Model M 3104	Electronics for Medicine, Inc.	CCK	Class II	1978-01-30
K780091	Micropulse 22U	Edwards Pacemaker Systems	DXY	Class III	1978-01-30
K780086	Infusion Apparatus, Powered	Ohio Medical Products	FRN	Class II	1978-01-30
K780085	Cane/reacher	Fred Sammons, Inc.	IPS	Class I	1978-01-30
K780084	Oxygen Therapy Kit	Thermadyne Holings Corp.	CAN	Class I	1978-01-30
K780066	Cardiac Pacer, Model 208	Cordis US Corp.	DXY	Class III	1978-01-30
K780017	Auto. Slide Stainer	Honeywell, Inc.	KPA	Class I	1978-01-30
K780013	Serum Glutamic Oxaloacetic Transaminase	Macomb Chemical Co.	CIT	Class II	1978-01-30
K772426	17-Hydroxy Test	Hycel, Inc.	CDB	Class I	1978-01-30
K772368	Spectacle Frame, Op-Tite	Dentsply Intl.	HQZ	Class I	1978-01-30
K772361	Laser Immunonephelometric Analyzer	G.D. Searle and Co.	JQX	Class I	1978-01-30
K772358	Ethylene Oxide Sterili. Indicator	Bio-Medical Sciences, Inc.	JOJ	Class II	1978-01-30
K772313	X-Ray Co-Ordinator	Rinn Corp.	IWY	Class I	1978-01-30
K772288	Catheter, Cholangiogram, Operative	Gesco Intl., Inc.	GBZ	Class I	1978-01-30
K772241	Pulse Generator, Bipolar, Demand	Cardiac Pacemakers, Inc.	DXY	Class III	1978-01-30
K772240	Pulse Generator, Unipolar, Demand	Cardiac Pacemakers, Inc.	DXY	Class III	1978-01-30
K772239	Pulse Generator, Bipolar, Programmable	Cardiac Pacemakers, Inc.	DXY	Class III	1978-01-30
K772238	Pulse Generator, Unipolar, Programable	Cardiac Pacemakers, Inc.	DXY	Class III	1978-01-30
K772221	Lens, Hard Resin	Borani Intl.	HQG	Class I	1978-01-30
K772197	Pacemaker, Perm. & Temp., Electrode	Daig Corp.	DTB	Class III	1978-01-30
K772051	Mdl-201	Pacesetter Systems	DXY	Class III	1978-01-30
K772050	Tdl-100 B	Pacesetter Systems	DXY	Class III	1978-01-30
K770143	Tqc Calibration Reference for Platelets	Technicon Instruments Corp.	KRY	Class II	1978-01-30
K780060	Camera, Gamma	Ackerman-Schmehl Industries, Inc.	IYX	Class I	1978-01-26
K780058	Tampon, Heavy Duty, & Stick	Kimberly-Clark Corporation	HIL	Class II	1978-01-26
K780049	Specimen Collection Device	Urol, Inc.	FMH	Class I	1978-01-26
K780027	Accelerator, Linear, Med.	Emi Therapy Systems, Inc.	IYE	Class II	1978-01-26
K780020	Generator, Oxygen, Portable	Jet Research Center, Inc.	CAW	Class II	1978-01-26
K772423	Spiraflow Dialyzers	Bentley Laboratories, Inc.	FJI	Class II	1978-01-26
K772419	Heel or Elbow Protector	Fred Sammons, Inc.	FMP	Class I	1978-01-26
K772405	Tubing Clamp	Fred Sammons, Inc.	FFN	Class I	1978-01-26
K772402	Quadriplegic Urinary Drainage Valve	Fred Sammons, Inc.	FAQ	Class I	1978-01-26
K772366	Bag, Drainagew/adhesive; Prosthesis	Atlantic Surgical	FON	Class I	1978-01-26
K772365	Thermometer Sheaths	MEDLINE INDUSTRIES, LP - Northfield	FLK	Class II	1978-01-26
K772355	Blood Line Comp. Neg. Press. Pillow	Cordis US Corp.	FIW	Class II	1978-01-26
K772338	Syringe, Blood, Sampling, Arterial	C.R. Bard Inc	FMF	Class II	1978-01-26
K772336	Glove & Latex Finger Cots	Jamar Health Products, Inc.	FMC	Class I	1978-01-26
K772318	Dialyzer Standard, Code 5Dm1780	Travenol Laboratories, S.A.	FJG	Class II	1978-01-26
K772312	Filterset W/y-Injection Site, 0.2	Abbott Medical	FPB	Class II	1978-01-26
K772262	Trapeze Bar Knocked Down	Med Fusion Systems, Inc.	FNJ	Class I	1978-01-26
K772261	Trapeze Floor Base	Med Fusion Systems, Inc.	FNJ	Class I	1978-01-26
K772260	Telescoping Bedrails	Med Fusion Systems, Inc.	FNJ	Class I	1978-01-26
K772099	Printer	Miles Laboratories, Inc.	JJJ	Class I	1978-01-26