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 2026-10-22, 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 2851 of 3529

510(k) clearances, page 2851 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K863237	Hydroxylapatite Bone Graft Material	Richards Medical Co., Inc.	LYC	Class II	1986-12-29
K864918	Health Products, Inc. Orthoderm Therapy Chair	Health Products, Inc.	INO	Class II	1986-12-24
K864901	2000Lt Wheelchair	Invacare GmbH	IOR	Class I	1986-12-24
K864846	Radiographic - Leg Section	American Sterilizer Co.	KQS	Class I	1986-12-24
K864824	Infectious Tissue Kit	American Scientific Products			1986-12-24
K864805	Cloward Surgical Saddle	Surgical Equipment International, Inc.			1986-12-24
K864804	Cloward Disposable Armrests and Face Rest	Surgical Equipment International, Inc.			1986-12-24
K864801	The Keymed Hi-Light 250 Light Source	Keymed, Inc.	GCT	Class II	1986-12-24
K864736	Akro-Sil Plus	Akron Catheter, Inc.	KOD	Class II	1986-12-24
K864550	Caretex Shoe Covers	James River Corp.	FXP	Class I	1986-12-24
K864291	High Frequency Needle-Type Epilator	Multi-Channel Epilator	KCW	Class I	1986-12-24
K864185	Mcghan Longterm Mammary Expander, Rtv Design	Mcghan Medical Corp.	LCJ	Unclassified	1986-12-24
K864184	Mcghan Longterm Mammary Expander/gel-Saline Design	Mcghan Medical Corp.	LCJ	Unclassified	1986-12-24
K863271	Fasciculated S Rod	The Deca Co.			1986-12-24
K863239	Fasciculated Boat Rod	The Deca Co.			1986-12-24
K863215	Fasciculated I Rod	The Deca Co.			1986-12-24
K864783	Maclee/boin Medica Sterile Needle & Syringe 5Ml/cc	Mac Lee Medical Products	FMF	Class II	1986-12-23
K864782	Maclee/boin Medica Sterile Needle/syringe 10Ml/cc	Mac Lee Medical Products	FMF	Class II	1986-12-23
K864780	Maclee/boin Medica Sterile Needle & Syringe 1Ml/cc	Mac Lee Medical Products	FMF	Class II	1986-12-23
K864551	Biopsy Adapter #H4221bg	General Electric Co.	GDF	Class I	1986-12-23
K864754	Becker External Drainage & Monitor System Trocar	Pudenz-Schulte Medical Research Corp.			1986-12-22
K864746	Bremer Halo System	Bremer Orthopedics	HAX	Class II	1986-12-22
K864699	Fluorescence Concentration Analyzer (Fca)	Pandex Laboratories, Inc.	JZT	Class I	1986-12-22
K864531	Tissue Gram Stain	Sigma Diagnostics, Inc.	ICF	Class I	1986-12-22
K864482	Choice	Select Sources, Inc.	HIS	Class II	1986-12-22
K864409	Immpulse Coated Tube Theophylline Assay Reagents	Sclavo, Inc.	LER	Class II	1986-12-22
K864032	Em TENS Window Electrodes	Electromed Intl., Ltd.	GXY	Class II	1986-12-22
K863967	Specific Ige Fast(tm) Test II	3M Company	DHB	Class II	1986-12-22
K863965	Kenz-ECG 102	Compumed, Inc.	DXK	Class II	1986-12-22
K863908	Binax Strep a	Binax, Inc.	GTZ	Class I	1986-12-22
K863841	Tandem OTC Hcg Pregnancy Test for Consumer Use	Hybritech, Inc.	LCX	Class II	1986-12-22
K863716	Rnet System, IV Receiving Terminal, Transmitter	Futurecare Systems, Inc.			1986-12-22
K863494	Neonatal Physiological Monitor Model Pm 20	Advantage Medical Systems, Inc.	DRT	Class II	1986-12-22
K863466	M700 Stress Monitor	Kone Instruments, Inc.	DRT	Class II	1986-12-22
K862837	Omnifit Total Knee Prosthesis System	Osteonics Corp.	HSX	Class II	1986-12-22
K862812	Nellcor Mvp, Model N-1000	Nellcor, Inc.	DQA	Class II	1986-12-22
K862668	Healthphone(tm)	Carelink	DXH	Class II	1986-12-22
K862602	Axion IV Goldline Series	Ventura Medical Electronics	GZJ	Class II	1986-12-22
K861856	Nbp 488, Tpr 488	Siemens Medical Solutions USA, Inc.	DXN	Class II	1986-12-22
K863668	Omnifit (Tm) Total Knee Prosthesis System	Osteonics Corp.	JWH	Class II	1986-12-19
K864697	Ck 6000 Series, Towels	Currie Medical Specialties, Inc.	KKX	Class II	1986-12-18
K864692	Extension Sets	Salt Creek Medical Technologies	FPK	Class II	1986-12-18
K864633	Vitallium Hex-Drive Bone Screw System	Howmedica Corp.	HWC	Class II	1986-12-18
K864631	Moore's Straight & Thompson's Curved Stem Prosthe.	Downs Surgical, Ltd.			1986-12-18
K864596	Sterilite Sterilization Kit	Kimberly-Clark Corporation			1986-12-18
K864528	Towels	Elof Hansson, Inc.			1986-12-18
K864521	Angel Latex Surgical Gloves	Kim Intl. Trading Co.	KGO	Class I	1986-12-18
K864414	Seal Syringe (3Cc,5cc,12cc,20cc,30cc & 50Cc)	Seal Syringe Corp.	FMF	Class II	1986-12-18
K864405	Manan Contrast Media Administration Set	Manan Manufacturing Co., Inc.	FPA	Class II	1986-12-18
K864403	Monticelli Spinelli External Fixation System	Howmedica Corp.	LXT	Class II	1986-12-18