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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1479 of 3531

510(k) clearances, page 1479 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K023643	Macropore Surgical Barrier Film	Macropore Biosurgery, Inc.	MTZ	Class II	2003-02-21
K021945	Planmed Sophie & Sophie Classic (with Digispot and Cytoguide)	Planmed Oy	IZH	Class II	2003-02-21
K013856	Pmh 1000 Heated Humidifier	Pegasus Research Corp.	BTT	Class II	2003-02-21
K030410	Accousonic Plus, Model Ap-170	Metron Medical Australia, Pty, Ltd.	IMI	Class II	2003-02-20
K030266	Cem-Ostetic Bone; Cemo-10G, Cemo-20G, Cemo-30G, Cemo-40G, Cemo-60G, Cem0-Xxgc; Cemo-Xyz202005p, Cemo-Xyz20210p, Cemo-Xyz	Berkeley Advanced Biomaterials	MQV	Class II	2003-02-20
K030260	Gelbfish Flex Vascular Dilator	Vascumetrix, LLC	DRE	Class II	2003-02-20
K030236	Acumatch P-Series Porous Press-Fit Femoral Component	Exactech, Inc.	LPH	Class II	2003-02-20
K030196	Dyonics Power Control Unit	Smith & Nephew, Inc.	HRX	Class II	2003-02-20
K030193	Advance Less Conforming Tibial Component	Wrightmedicaltechnologyinc	HRY	Class II	2003-02-20
K024008	Small Bard Ventralex Patch	C.R. Bard Inc	FTL	Class II	2003-02-20
K023903	Wilson-Cook Endoscopic Clipping Device	Wilson-Cook Medical Inc.	PKL	Class II	2003-02-20
K023899	Dual Yellow Laser, Model D10b	Norseld Pty. Ltd.	GEX	Class II	2003-02-20
K023838	Luneau Sterile Tonometer Separation Prisms	Luneau SA	HKY	Class II	2003-02-20
K023630	Essex Aspiration/irrigation Instrument with Positioning Guide, Model Sy-1400	Guidant Corporation, Cardiac Surgery	GCJ	Class II	2003-02-20
K023351	Magic Infusion Catheter	Advanced Interventional Technologies, LLC	KRA	Class II	2003-02-20
K022709	Medlite Q-Swithced Laser	Continuum Electro-Optics, Inc.	GEX	Class II	2003-02-20
K020595	Xenostrip-Tv Trichomonas Cassette Test, Model C1383.01	Xenotope Diagnostics, Inc.	JWZ	Class I	2003-02-20
K030354	Biscover Liquid Polish Kit, Biscover Liquid Polish and Biscover Viscosity Modifier	Bisco Inc	EBD	Class II	2003-02-19
K030157	Powder Free Latex Examination Gloves, Sterile with Protein Content Labeling Claim	WRP Asia Pacific Sdn Bhd	LYY	Class I	2003-02-19
K030148	Disposable Powder Free Vinyl Synthetic Exam Gloves White Color	Shanghai Palomar Mountain Industries, Inc.	LYZ	Class I	2003-02-19
K030137	Medtronic Minimed Sof-Site Infusion Set, Models Mmt-358S6, Mmt-358M6, Mmt-358L6, Mmt-358S9, Mmt-358M9, and Mmt-358L9	Avail Medical Products, Inc.	FPA	Class II	2003-02-19
K024363	Nexus Injection Site (Nis), Model Nis-1	Nexus Medical, LLC	FPA	Class II	2003-02-19
K024302	Precision Capillaries for Micromanipulation	Brinkmann Instruments, Inc.	MQH	Class II	2003-02-19
K024162	Spife 3000 Titan Gel Igg Ief Kit, Model 3389	Helena Laboratories, Corp.	CFF	Class II	2003-02-19
K023906	Pathway Cts2000 Pelvic Floor Training System	The Prometheus Group	KPI	Class II	2003-02-19
K023882	The Hedrocel Trabecular Metal Reconstruction System	Implex Corp.	EZX	Class II	2003-02-19
K023603	Endo-Glide Guidewire	Endo-Therapeutics, Inc.	OCY	Class II	2003-02-19
K023463	Cvsi Peripheral Balloon Catheter; Cvsi Catheter Inflation Unit	Cryo Vascular Systems, Inc.	DQY	Class II	2003-02-19
K023238	Mcpulse	Meridian AG	JOM	Class II	2003-02-19
K022891	The Breathe Ez Anti-Snoring Device	D&S Redhage	LRK	Class II	2003-02-19
K022814	Multiple Nitrile Examination Gloves (Powdered)	Pt. Smartglove Indonesia	LZA	Class I	2003-02-19
K022340	Travelair Portable Compression System	Dynamic Air, Inc.	JOW	Class II	2003-02-19
K030249	Surgical Titanium Mesh System	Depuyacromed	MQP	Class II	2003-02-14
K024097	Summit Medical Ltd Celltrans Postoperative Autotransfusion Set, Models Ab400-10, Ab400-12, Ab400-14	Summit Medical, LLC	CAC	Class II	2003-02-14
K024094	4 Seasons	Ivoclar Vivadent, Inc.	EBF	Class II	2003-02-14
K024071	Guidant Syncrus Internal Cardioversion System	Guidant Corporation, Cardiac Surgery	NHW	Class II	2003-02-14
K024045	Contaflex Gm3 49% (Acofilcon B) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)	Contamac Ltd.	LPL	Class II	2003-02-14
K023953	St. George Technology, Inc Perfection Plus Disposable Prophy Angle	St. George Technology, Inc.	EGS	Class I	2003-02-14
K023854	Samaritan AED, Model Sam-01	HeartSine Technologies Ltd	MKJ	Class III	2003-02-14
K023848	Model 675Ge-64 Peripheral Vascular Coil Consisting of Model 665Ge-64: Lower Extremity Flexible Array and Model 538Ge-64:	Igc-Medical Advances, Inc.	MOS	Class II	2003-02-14
K023843	Smartstitch M-Connector, Model Om-8005; Smartstitch Actuation Handle, Model Om-8500; and Smartstitch Suture Cartridge	Opus Medical, Inc.	OCW	Class II	2003-02-14
K023824	Albumin Cobalt Binding Test (Acb Test)	Ischemia Technologies, Inc.	NJV	Class II	2003-02-14
K023787	Tai-Chi and Master Acupuncture Needles	Lhasa Medical, Inc.	MQX	Class II	2003-02-14
K023761	Plateletworks, Models Pw-a, Pw-C	Helena Laboratories, Corp.	JOZ	Class II	2003-02-14
K023407	Atac Pak Creatinine Reagent and Atac Calibrator	Elan Diagnostics	CGX	Class II	2003-02-14
K023050	Reliant Btl 5000 Puls Electrical Stimulation System, Reliant Btl 5000 Sono Ultrasound System, Reliant Btl 5000 Combi	Reliant Technologies, Inc.	IMG	Class II	2003-02-14
K022813	Steerable Guidewire	Lake Region Mfg., Inc.	DQX	Class II	2003-02-14
K022071	Embol-X Aortic Filters,etra-Small,small,medium,large,extra Large,models Cf26000.cf29000,cf32000,cf35000,cf4000	Embol-X, Inc.	DTM	Class II	2003-02-14
K030307	Davol Arthrovent Outflow Tubing	Davol, Inc.	HRX	Class II	2003-02-13
K024038	N Latex Iga	Siemens Healthcare Diagnostics Inc.	CZP	Class II	2003-02-13