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 2026-10-21, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3012 of 3529

510(k) clearances, page 3012 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K844941	Cfe Acetabular Cup	Zimmer GmbH	JDI	Class II	1985-03-05
K844906	Threaded Titanium Metal Backed Acetabular Cup	Depuy, Inc.	LZO	Class II	1985-03-05
K844868	Chlamydia Group Cf Antigen	Hillcrest Biologicals	GPW	Class I	1985-03-05
K844799	Artisan Folding Wheelchairs	Artisan Wheel Chair Manufacturers	IOR	Class I	1985-03-05
K844782	Nsi Elt-D Diluting Fluid 4000Ml	Nobel Scientific Industries, Inc.	GIF	Class I	1985-03-05
K844712	Models 841,842,843,851,852 & 853 Elevating Tractio	Tri W-G, Inc.	INQ	Class I	1985-03-05
K844711	Models 134, 135 & 136 Transfer Cart/table	Tri W-G, Inc.	INK	Class II	1985-03-05
K844708	Tri-Count Calibrator	Hematology Marketing Assoc.	KSA	Class II	1985-03-05
K844695	Echo Type 4 Cf Antigen	Hillcrest Biologicals	GNL	Class I	1985-03-05
K844645	Qbc Centrifugal Hematology Analyzer	BD Becton Dickinson Vacutainer Systems Preanalytic	GKZ	Class II	1985-03-05
K844617	Excel Tech Mst-7 Isoelectronic Therapy Device	Excel Tech., Ltd.	IPF	Class II	1985-03-05
K844583	Tsh-Stat	Nuclear Medical Laboratories, Inc.	JLW	Class II	1985-03-05
K844573	Absorbable Gauze Products	Medicon Co., Ltd.	EFQ	Unclassified	1985-03-05
K844489	Electronic Muscle Stimulator	Beverly Hills Exercise Equipment	IPF	Class II	1985-03-05
K844135	Plasma Cyclic Adenosine Monophosphate by Radioimmu	Immuno Nuclear Corp.	CHO	Class II	1985-03-05
K843911	Access C	Advanced Technology Laboratories, Inc.	JOP	Class II	1985-03-05
K843778	Mayo Elbow II	Zimmer GmbH			1985-03-05
K842668	Liqui-Heme Hemoglobin Calibrators	Biodiagnostic Intl	KRZ	Class II	1985-03-05
K841427	Accu-O-Matic	Myomed, Inc.	GZJ	Class II	1985-03-05
K850510	Emem W/neaa-Minimum Essential Med. W/non-Ess. Amin	Mediatech, Inc.	KIT	Class I	1985-03-04
K850376	Terumo Sensibead Eia Tsh Kit	Terumo Medical Corp.	JLW	Class II	1985-03-04
K850201	Leeco Concep-7-Bhcg Leiad II	Leeco Diagnostics, Inc.	JHI	Class II	1985-03-04
K850200	Suction Regulator 7700 Series	Boehringer Laboratories, LLC	KDP	Class II	1985-03-04
K850191	Digilab 750 Automated Perimeter W/ibm Person/compu	Bio-Rad	HPT	Class I	1985-03-04
K850159	Tandem Icon Hcg Immunoenzymetric Assay Kit	Hybritech, Inc.	JHI	Class II	1985-03-04
K850124	Chlamydial Transport Media	Hillcrest Biologicals	JSM	Class I	1985-03-04
K844696	Trogide	Carmel Medical Devices	BTR	Class II	1985-03-04
K844346	Fisher Diagnostics Pregnaclone Slide Pregnancy Tes	Fisher Diagnostics	JHJ	Class II	1985-03-04
K844201	Hi-Lo Temp Thermocouple to Thermister Adaptor	Mallinckrodt Critical Care	FLL	Class II	1985-03-04
K850660	Suntech Models 3001 Allstar & 3401 Galaxy	Suntech USA, Inc.	FTC	Class II	1985-03-01
K850656	Cook 331T Unipolar Cardiac Pulse Generator W/telem	Cook Pacemaker Corp.	DXY	Class III	1985-03-01
K850590	Spq Test System for C-Reactive Protein	Applications Lab	DCK	Class II	1985-03-01
K850585	Spq Test System for Complement C4	Applications Lab	DBI	Class II	1985-03-01
K850583	Spq Test System for Immunoglobulin G	Applications Lab	DEW	Class II	1985-03-01
K850582	Spq Test System for Immunoglobulin a	Applications Lab	CZP	Class II	1985-03-01
K850542	Surgicutt - Bleeding Time Device	Accriva Diagnostics, Inc.	JCA	Class II	1985-03-01
K850502	H/g Cup Positioner (1520) Left-500Pcs Right 500Pcs	The Huxley Instrument Corp.			1985-03-01
K850501	Lister Bandage Scissors (6-0064)-4.5 500Pcs.	The Huxley Instrument Corp.			1985-03-01
K850500	Lister Bandage Scissors 6-0063(3,5 - 500 Pcs	The Huxley Instrument Corp.			1985-03-01
K850497	Micro-Aire Generic Burs & Drills	Micro-Aire Surgical Instruments, Inc.	GFF	Class I	1985-03-01
K850483	Micro-Aire Sternum Saw Replacement Blades	Micro-Aire Surgical Instruments, Inc.	DWH	Class I	1985-03-01
K850454	Cardio-3 Channel Electrocardiograph	Zimmer Elektromedizin GmbH	DPS	Class II	1985-03-01
K850383	Prl Quik Ria Kit	Pacific Biotech, Inc.	CFT	Class I	1985-03-01
K850381	Magnesium Reagent for Demand Analyzer	Advanced Biomedical Methods, Inc.	JGJ	Class I	1985-03-01
K850380	Inorganic Phosphorous for Demand Analyzer	Advanced Biomedical Methods, Inc.	CEO	Class I	1985-03-01
K850379	Direct Bilirubin for Demand Analyzer	Advanced Biomedical Methods, Inc.	CIG	Class II	1985-03-01
K850378	Ldh Reagent for Demand Analyzer	Advanced Biomedical Methods, Inc.	CFJ	Class II	1985-03-01
K850373	Abbott RF Eia Diagnostic Kit	Abbott Medical	DHR	Class II	1985-03-01
K850207	Penpoint, Flexible & Spot Markers & Radoactive Rul	Syncor Intl. Corp.			1985-03-01
K850156	ECG Patient Monitor 301	Rigel Medical Electronics, Inc.	DRT	Class II	1985-03-01