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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2815 of 3530

510(k) clearances, page 2815 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K871394	Theophylline Fpia Calibrators	Sigma Diagnostics, Inc.	DLJ	Class II	1987-06-01
K871383	Fetalert Adr Fetal Monitor	Advanced Technology Laboratories, Inc.	HGM	Class II	1987-06-01
K871334	Lase System II	Lase, Inc.	GEX	Class II	1987-06-01
K870890	Alkaline Phosphatase Indolyl Blue Reagent	Helena Laboratories, Corp.	CIN	Class II	1987-06-01
K870831	Pda699/pda700 Protamine Dose Assay for Hep. Neutra	Accriva Diagnostics, Inc.	JPA	Class II	1987-06-01
K870786	Axial Compression Screw	Straub Clinic and Hospital	KTT	Class II	1987-06-01
K870746	Stanbio Alpha-Amylase Test Set, Catalog 0180-715	Stanbio Laboratory	JFJ	Class II	1987-06-01
K870413	Percutaneous Sheath W/wo Medi. (5,6,7,8,8.5Fr)	Medical Surgical Concepts, Inc.	DRE	Class II	1987-06-01
K870197	Kdi Quik Test(tm) Marijuana Screen	Keystone Diagnostics, Inc.	LDJ	Class II	1987-06-01
K871945	Microlab at	Hamilton Co	JTC	Class I	1987-05-29
K871911	The F Spoon Hand Held Fluoroscopic Compression	F. Spoon Co.	JAA	Class II	1987-05-29
K871860	Novapath C. Trachomatis Direct Spec Collection Kit	Bio-Rad	LIO	Class I	1987-05-29
K871778	Digispot Imager	Siemens Gammasonics, Inc.	LMC	Class II	1987-05-29
K871689	Spectacle Frame - Lorraine	Roseburg SA	HQZ	Class I	1987-05-29
K871688	Spectacle Frame - Danielle	Roseburg SA	HQZ	Class I	1987-05-29
K871649	Classic 70 Lens	Korea Asahi Optical Co., Ltd.	HQC	Class II	1987-05-29
K871457	First Aid Kit, Eye Dressing	Fraass Survival Systems, Inc.	LRR	Not classified	1987-05-29
K871433	Ppg Biomedical Ventilator Model Av 400	Ppg Industries, Inc.	CBK	Class II	1987-05-29
K871387	Second Nature(tm)	Advanced Clinical Products, Inc.	KNX	Class II	1987-05-29
K871386	Breathing Circuit	Dryden Corp.	CAI	Class I	1987-05-29
K871359	Check-Mate and Check-Mate [+]	Veritech, Inc.	EFW	Class I	1987-05-29
K871295	Adaptalite* Porcelain Veneer Cementation System	Johnson & Johnson Professionals, Inc.	EBF	Class II	1987-05-29
K871270	Perform Denture Base Resin	Ipco Corp.	EBF	Class II	1987-05-29
K871255	Modified Hercon Antiseptic Transparent Dressing	Hercon Laboratories Corp.	FRO	Unclassified	1987-05-29
K871236	Hollow Fiber Dialyzer Focus 70,90,120,90H,120h	National Medical Care, Medical Products Div., Inc.	FJI	Class II	1987-05-29
K871222	Tantone Multi-Day #633 TENS Electrode	Uni-Patch, Inc.	GXY	Class II	1987-05-29
K871202	Flashpak Container System	Performance Instruments Corp.	FRG	Class II	1987-05-29
K871158	Sibis Remote Actuator	Human Technologies, Inc.	HCB	Class II	1987-05-29
K871107	Vasotrain 447	Henley Intl.	IRO	Class I	1987-05-29
K870997	Sola UV Gard(tm) Sunglasses	Sola-Syntex Ophthalmics	HQY	Class I	1987-05-29
K870911	Indwelling Blood Carbondioxide Partial Pres. Analy	American Bentley	CCC	Class II	1987-05-29
K870807	Bks-1000 Refractive Set Use in Keratorefractive	Allergan	HNO	Class I	1987-05-29
K870235	Omnifit II Hip Prostheses: Cement Fixation	Osteonics Corp.	JDI	Class II	1987-05-29
K871907	Ld Presumpto Quad	BD Becton Dickinson Vacutainer Systems Preanalytic	JTO	Class I	1987-05-28
K871659	Ims-2000S Stress Monitor	Integrated Medical Systems Inc	DXG	Class II	1987-05-28
K871633	Tru-Sound Ultrasound Therapy Unit	Tru-Trac Therapy Products, Inc.	IMJ	Class II	1987-05-28
K871484	Cobas Fp Reagents for Theophylline & Calibrators	Roche Diagnostic Systems, Inc.	LGS	Class II	1987-05-28
K871226	Syphilis Serological Reagents	New Horizons Diagnostics Co.	GMQ	Class II	1987-05-28
K871207	Omron Digital Blood Pressure Monitor Hem-401C	Omron Electronics, Inc.	DXN	Class II	1987-05-28
K871188	Lithium Internal Standard 1500 Meq/l #60086	In Vitro Diagnostics, Inc.	JIS	Class II	1987-05-28
K871187	Lithium Internal Standard 3000 Meq/l #60084	In Vitro Diagnostics, Inc.	JIS	Class II	1987-05-28
K871186	Cesium Diluent 1.5 Mmol Cs/l #60087	In Vitro Diagnostics, Inc.	JIS	Class II	1987-05-28
K871185	Lithium Internal Standard 1 Meq/l #60085	In Vitro Diagnostics, Inc.	JIS	Class II	1987-05-28
K871184	Flame Photometer Standard #60083 160 Na/8k	In Vitro Diagnostics, Inc.	JIX	Class II	1987-05-28
K871183	Flame Photometer Standard #60082 140 Na/5k	In Vitro Diagnostics, Inc.	JIX	Class II	1987-05-28
K871182	Flame Photometer Standard #60081 120 Na/2k	In Vitro Diagnostics, Inc.	JIX	Class II	1987-05-28
K871068	Disposable Laser Protective Drape for CO2 Laser	Lifestream Int'L, Inc.	KKX	Class II	1987-05-28
K871028	Ciba Corning Model 664/Fast 4 System	Ciba Corning Diagnostics Corp.	JGS	Class II	1987-05-28
K870627	Affinity (Tm) Hcg Immunit (Tm)	BD Becton Dickinson Vacutainer Systems Preanalytic	JHI	Class II	1987-05-28
K870016	Arterial Blood Gassing Monitoring System (Abg)	Simplivia Healthcare Ltd.	DTB	Class III	1987-05-28