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 2837 of 3529

510(k) clearances, page 2837 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K863946	Porex(tm) Extra-Ocular Orbital Implant	Porex Medical	HQX	Class II	1987-02-27
K863943	Porex(tm) Eye Sphere Implant	Porex Medical	HPZ	Class II	1987-02-27
K863364	Diagnostic Ultrasonic Transducer	Toshiba Medical Systems	ITX	Class II	1987-02-27
K863346	Professional Disinfection System (Pds)	Ciba Vision Care	LPN	Class II	1987-02-27
K862686	Kontron Sigma 1Sc Digital Echocardiography System	Kontron Instruments, Inc.	ITX	Class II	1987-02-27
K862325	The Injector	American Medical Innovations, Inc.	KZH	Class II	1987-02-27
K870703	Skan D-Scope	Medx, Inc.	IYX	Class I	1987-02-26
K870701	Kodak X-Omatic Identification Camera Digital	Eastman Kodak Company	JAC	Class I	1987-02-26
K870591	Elevator, Cobb Spinal	Military Engineering, Inc.	GEG	Class I	1987-02-26
K870565	Kodak X-Omatic Ident. Camera, Models 2 and 2L	Eastman Kodak Company	JAC	Class I	1987-02-26
K870510	Danniflex 400I	Buckman Co., Inc.	BXB	Class I	1987-02-26
K870502	Culturia Macconkey-Mug/modified Tsa Systems	Clinical Convenience Products, Inc.	JSI	Class I	1987-02-26
K870476	Quickie Rx Prescription Wheelchair	Motion Designs, Inc.	IOR	Class I	1987-02-26
K870449	Spottest Pyr Reagent	Difco Laboratories, Inc.	JTO	Class I	1987-02-26
K870431	Gauze, Absorbent, Iodoform Impregnated	Steridyne Laboratories, Inc.	FRO	Unclassified	1987-02-26
K870379	Ise Compensation Sera	Boehringer Mannheim Corp.	JIS	Class II	1987-02-26
K870352	Rubycell(tm) Synthetic Island Dressing	Bioderm, Inc.	FRO	Unclassified	1987-02-26
K870298	Redman Accessories	Redman, Inc.	KNO	Class I	1987-02-26
K870083	Ferray Extractor	Terray Manufacturing, Inc.	HWB	Class I	1987-02-26
K865054	Stimutron Model 100	The Austin-Lenick Co.	IPF	Class II	1987-02-26
K865048	Eclipse+, Model Number 7723	Medtronic, Inc.	GZJ	Class II	1987-02-26
K865027	Irradiator for Biological Materials, Ibl-137C	Cis-Us, Inc.	MOT	Unclassified	1987-02-26
K864854	View(tm) Image Processing and Viewing Station	Virtual Imaging, Inc.	LLZ	Class II	1987-02-26
K864752	Abbott Testpack(tm) Strep a Positive Control	Abbott Medical	GTY	Class I	1987-02-26
K864368	Schuldt* Plus 8 t.e.n.s. Device	Schuldt Laboratories, Inc.	GZJ	Class II	1987-02-26
K864125	Cpreviver	Augerscope, Inc.	BTM	Class II	1987-02-26
K862873	Iuc - Intrauterine Catheter	Utah Medical Products, Inc	KXO	Class II	1987-02-26
K862820	Ladd/steritek Icp Monitor, Cat. No. P3000	Ladd Research Industries, Inc.	GWM	Class II	1987-02-26
K862414	Fuji Cr Imaging Plate	Parexel Intl. Corp.	EAM	Class I	1987-02-26
K870472	Acute Peritoneal Dialysis Kit	Quinton, Inc.	FKO	Class II	1987-02-25
K870406	Smi Digitron	American Dade	JQW	Class I	1987-02-25
K870398	Pap-Pak Cytobrush Kit	Medical Packaging Corporation	HHT	Class II	1987-02-25
K870361	Tampax Closed-End Flushable Tampon, Slender Regu.	Tambrands Inc.	HEB	Class II	1987-02-25
K870360	Tampax Closed-End Flushable Tampon, Super Plus	Tambrands Inc.	HEB	Class II	1987-02-25
K870359	Tampax Closed-End Flushable Tampon, Orig. Regular	Tambrands Inc.	HEB	Class II	1987-02-25
K870358	Tampax Closed-End Flushable Tampon, Super	Tambrands Inc.	HEB	Class II	1987-02-25
K870270	Modified Bio. Hemodialysis & Hd-1000 Disp. Cart.	Ash Medical Systems, Inc.	FKT	Class II	1987-02-25
K870113	Thermal Jacket for i.v. Fluid Bags	Thermal Medical Systems, Inc.	KPE	Class II	1987-02-25
K864995	Osseointegrated Fixtures for Use in Dental Implant	Vent-Plant Corporation, Inc.	DZE	Class II	1987-02-25
K864975	Laserscope Omniplus Photosurgical System for (ENT)	Laserscope	EWG	Class II	1987-02-25
K864949	Instruction Change for Right Atrial/raaf Catheter	Quinton, Inc.	FOZ	Class II	1987-02-25
K864888	Microtrak Chlamydia Trachomatis Direct Speci. Test	Syva Co.	LJP	Class I	1987-02-25
K864855	Amerlex-M Progesterone Radioimmunoassay Kit	Amersham Corp.	JLS	Class I	1987-02-25
K864708	Sr 3/60 Nf Denture Mater. & Self-Cure Dent. Resin	Ivoclar USA, Inc.	EBI	Class II	1987-02-25
K864679	Dzidra Glass for Use in General Medical	Glen Whitten, Dds			1987-02-25
K864678	Dzidra Glass for Use in Neurology	Glen Whitten, Dds			1987-02-25
K864656	Dzidra Glass for Use in Ophthalmology	Glen Whitten, Dds			1987-02-25
K864655	Dzidra Glass for Use in Dentistry	Glen Whitten, Dds			1987-02-25
K864557	710 Plus	Ciba Corning Diagnostics Corp.	JQP	Class I	1987-02-25
K864322	Mpx System, Glucose Test System	Lifescan, Inc.	CGA	Class II	1987-02-25