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 3413 of 3526

510(k) clearances, page 3413 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K782077	Lancer Ice Cube	Sherwood Medical Industries	JRM	Class I	1979-04-03
K781651	Health Point	Anritsu America Co.	BWK	Unclassified	1979-04-03
K790071	Endoscope and Accessories	Olympus Corp.	GCP	Class II	1979-04-02
K790074	Medtronic Model 6971	Medtronic, Inc.	DTB	Class III	1979-03-29
K790536	Clearview	Hipoint Research, Inc.	KXJ	Class II	1979-03-28
K790488	Interplanta Sp Total Hip Prosthesis	Waldemar Link GmbH & Co. KG	JDI	Class II	1979-03-28
K790466	U-Mat	Engineering Dynamics Corp.	IYX	Class I	1979-03-28
K790459	Cement Dispenser Cement Mixer	Dow Corning Wright	JSG	Class I	1979-03-28
K790451	X-Ray Units, Gx-101, Ucis-510 and Gx-111	General X-Ray, Inc.	IZL	Class II	1979-03-28
K790425	Ionescu-Shiley Composite Conduit-Pulmoni	Shiley, Inc.			1979-03-28
K790395	Vidicam Video Reprograph	Vidicam	JAK	Class II	1979-03-28
K790370	Bunn Model #40 Low Pressure Alarm	The John Bunn Co.	CAP	Class II	1979-03-28
K790361	Recirculation Filter Model RF-10	Bentley Laboratories, Inc.	KRJ	Class II	1979-03-28
K790523	Argyle Esophageal Stethoscope	Sherwood Medical Industries	BZW	Class I	1979-03-27
K790435	Intersept* Blood Filter W/ Tubing Bypass	Surgikos, Inc.	DTM	Class II	1979-03-27
K790316	Electrode, Electroflex	Andover Medical, Inc.	GXY	Class II	1979-03-27
K790300	Meta III	Hittman Medical Systems	DPS	Class II	1979-03-27
K790534	Mersilene Sutures	Hancock Laboratories, Inc.	KRH	Class II	1979-03-26
K790512	Portable X-Ray Unit	General X-Ray, Inc.	IZL	Class II	1979-03-26
K790511	Mobile X-Ray Unit	General X-Ray, Inc.	IZL	Class II	1979-03-26
K790499	Multiple Pinhole Tomographic Collimoter	Engineering Dynamics Corp.	IYX	Class I	1979-03-26
K790472	Burron Vented Needle	National Patent Development Corp.	GAA	Class I	1979-03-26
K790467	Surgical Eye Sponge	Medtech Intl., Inc.	EFQ	Unclassified	1979-03-26
K790463	Modu-Set Collimotor	Medtronic, Inc.	IYX	Class I	1979-03-26
K790443	Portable X-Ray Unit	General X-Ray, Inc.	IZL	Class II	1979-03-26
K790405	Anchor Brand Count-Tainer	Anchor Products Co.	MMK	Class II	1979-03-26
K790393	Portable X-Ray Unit, Matrix S Gx-101	General X-Ray, Inc.	IZL	Class II	1979-03-26
K790392	510 Carbinette X-Ray Unit	General X-Ray, Inc.	IZL	Class II	1979-03-26
K790389	Gauze & Cotton Sponges	Medtech Intl., Inc.	GDY	Class I	1979-03-26
K790388	Mevatron 60	Siemens Medical Laboratories, Inc.	IYE	Class II	1979-03-26
K790274	Bg Proximal Femur	Howmedica Corp.	JDL	Class III	1979-03-26
K790223	Dialyzer, Cd-800 Coil	Travenol Laboratories, S.A.	FHS	Class II	1979-03-26
K790509	Cardiocassette II, Ambulatory ECG System	Cambridge Instruments, Inc.	DSH	Class II	1979-03-23
K790456	Series 7000	Narco Mckesson Co.	BSZ	Class II	1979-03-23
K790455	Microflush	Medex, Inc.	KRA	Class II	1979-03-23
K790394	Defibrillator Interal Paddle Test Load	Physio Control, Inc.	DRL	Class II	1979-03-23
K790035	Ambu Suction Booster	Narco Air-Shields	CBC	Class II	1979-03-23
K790527	Burnett-Ketchum Dynamic Hand Exerciser	Maddak, Inc.	JFA	Class I	1979-03-22
K790410	Adult Zee-Frame	Equilibrated Bio Systems, Inc.	JAY	Class I	1979-03-22
K790385	Kotex Tube and Stick Tampon	Kimberly-Clark Corporation	HEB	Class II	1979-03-22
K790342	Somatom Sd	Siemens Corp.	JAK	Class II	1979-03-22
K790333	Nad Scavenging Relief Valve	Draeger, Inc.	CBN	Class II	1979-03-22
K790213	Generator, R-Wave	Amr Co.	IYY	Class I	1979-03-22
K790418	Model 8100 Pre-Filled Intrauterine	GE Medical Systems Information Technologies, Inc.	KXO	Class II	1979-03-21
K790404	Dtt System	Depuy, Inc.	KWQ	Class II	1979-03-21
K790403	Emit Quinidine Assay	Syva Co.	LAR	Class II	1979-03-21
K790396	Ultrasonic Diagnostic System	Hoffrel Instruments, Inc.	IYO	Class II	1979-03-21
K790380	Low-Tox-H Rabbit Complement	Cederlane Labs, Ltd.	KTQ	Class I	1979-03-21
K790368	Modified Thayer Martin Agar	Biomedia, Inc.	JTY	Class II	1979-03-21
K790359	Halothane Vaporizer 950, & Enflurane 951	Siemens Corp.	CAD	Class II	1979-03-21