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 3434 of 3526

510(k) clearances, page 3434 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K781424	Generators: Udl-201B, Bdl-201B, Mdl-201B	Pacesetter Systems	DXY	Class III	1978-09-27
K781410	Rialyze Vitamin B-12 Test	Ames Div., Miles Laboratories, Inc.	CDD	Class II	1978-09-27
K781409	Immo Phase, Thyroid Hormone	Corning Medical & Scientific	JLW	Class II	1978-09-27
K781407	Erm-101	Cynergy	DRT	Class II	1978-09-27
K781383	Interface Cardiotomy Blood Filter	Medical, Inc.	JOD	Class II	1978-09-27
K781343	Resurface Proshesis	Aesculap Instruments Corp.			1978-09-27
K781325	Markii Ventimasks	Vickers America Medical Corp.	BYF	Class I	1978-09-27
K781320	Shortwave Therapy Appar. Curamed 401	General Theraphysical, Inc.	IMJ	Class II	1978-09-27
K781316	Pulsed and Continuous Shortwave Appar.	General Theraphysical, Inc.	IMJ	Class II	1978-09-27
K781277	Stimulator, Nerve, Transcutaneous	Psitron	GZJ	Class II	1978-09-27
K781232	Ippb Assembly W/nebulizer	Rtec	NHJ	Class II	1978-09-27
K781105	Tonometer, Digiton	Ical, Inc.	HKY	Class II	1978-09-27
K781103	Spectrascan	Medishield, Inc.	DAT	Class II	1978-09-27
K781081	Emit Mca Program Tape	Instrumentation Laboratory Co.	JQP	Class I	1978-09-27
K781073	Pulmo-Sonic	The Devilbiss Co.	CCQ	Class I	1978-09-27
K781021	Air Bubble Detector	3M Health Care, Sarns			1978-09-27
K780940	Generator, Pulse, Model 160B	Telectronics, Inc.	DXY	Class III	1978-09-27
K772226	Pacemaker, Model 225 & 227	Intermedics, Inc.	DXY	Class III	1978-09-27
K781541	Flometer	Chemetron Medical Products, Inc.	CAX	Class I	1978-09-26
K781509	Zee-Frame	Equilibrated Bio Systems, Inc.	JAY	Class I	1978-09-26
K781508	Waterpath Scanning Option	G.D. Searle and Co.	IYO	Class II	1978-09-26
K781359	Model 80032A, Obstetrical Telemetry	Hewlett-Packard Co.	HGM	Class II	1978-09-26
K781163	Electrode, Deip.	Datascope Corp.	DRX	Class II	1978-09-26
K781139	Muscle Stimulator, Electronic	Thor Medical Instruments, Inc.	IPF	Class II	1978-09-26
K781113	Muscle Stimulator, Electrical	Rich-Mar Corp.	IPF	Class II	1978-09-26
K781050	Dlc 500, Double Lumen Catheter	Hemodialysis, Division of the	KOC	Class II	1978-09-26
K781526	Silastic U-Tube Kit	Dow Corning Corp. Healthcare Industries Materials	GBO	Class I	1978-09-20
K781490	Tillman Hipsurface Replacement	Waldemar Link GmbH & Co. KG	KXA	Class II	1978-09-20
K781465	Microsurgical Knives, 20, 30, 45	Cerenovus, Inc.	HNN	Class I	1978-09-20
K781457	Foley Catheters	Intermed, Inc.	KOD	Class II	1978-09-20
K781454	Linde Oxygen Concentrator Model Loc-Hca	Union Carbide Corp.	CHW	Class II	1978-09-20
K781421	Bioscan E12	Clinifax Industries, Ltd.	JJS	Class I	1978-09-20
K781417	Precision Gas Mixer	Medicor USA, Ltd.	LCH	Class I	1978-09-20
K781411	Corneal Cutter and Accessories	Cerenovus, Inc.	HRH	Class I	1978-09-20
K781400	Hemovac Tubing Material Change	Snyder Laboratories, Inc.	GCY	Class I	1978-09-20
K781399	Teca Model B9 Electromyograph	Teca, Inc.	IKN	Class II	1978-09-20
K781387	Insta-Pulse Heart Rate Monitor	Bio Sig Instruments, Inc.	DRT	Class II	1978-09-20
K781375	Comform Absorbant Incontinence Pads	Kimberly-Clark Corporation	EYQ	Class I	1978-09-20
K781373	Ostomy Appliance W/deodorizing Filter	Hollister, Inc.	EXB	Class I	1978-09-20
K781371	Bone Marrow Aspiration Kit	Ferris Mfg. Corp.	GAA	Class I	1978-09-20
K781370	Ms-2 Automated Urine Screening System	Abbott Medical	JXA	Class I	1978-09-20
K781358	Sequential Cuff Inflation Device	Medasonics, Inc.	JOW	Class II	1978-09-20
K781357	T.e.d. Sequential Compression Sleeves	Kendall Research Center	JOW	Class II	1978-09-20
K781292	Cardiopneumograph	Street Electronics Corp.	DRT	Class II	1978-09-20
K781264	Pab Convenience Tray	Waters Assoc., Inc.	GAA	Class I	1978-09-20
K781256	Cathode Ray Tube Med. Display	Rae Medical Corp.	DXJ	Class II	1978-09-20
K781255	Digital Panel Meter	Rae Medical Corp.	DRT	Class II	1978-09-20
K781245	Lung Exer. Bag, Post-Op, Modified	Dytek Corp.	BWF	Class II	1978-09-20
K781243	Mercury Disp. Capsule	Lee Pharmaceuticals	DZS	Class I	1978-09-20
K781157	Stimulator, Nerve, Transcutaneous	Medtech Intl., Inc.			1978-09-20