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 2026-11-02, 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 2509 of 3531

510(k) clearances, page 2509 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K901088	Low Volume Bifurcated IV Extension Set	Marquette Medical, Inc.	FPA	Class II	1990-10-04
K900780	Cysticercosis Serological Reagents	Lmd Laboratories	MDJ	Class I	1990-10-04
K900639	Dynatron 350 Emg/biofeedback Analyzer	Dynatronics Laser Corp.	HCC	Class II	1990-10-04
K900336	V Set	Go Medical Industries Pty., Ltd.	FPA	Class II	1990-10-04
K904324	Latex Examination Glove	Gallimore Ent., Inc.	LYY	Class I	1990-10-03
K904283	Ps Medical Cranial Hand Drill	Pudenz-Schulte Medical Research Corp.	HBG	Class II	1990-10-03
K904238	Kodak X-Mat 270 Ra Processor	Eastman Kodak Company	IXW	Class II	1990-10-03
K904217	Pro-Lok (Tm) Extension Sets	VLV Associates, Inc.	FPA	Class II	1990-10-03
K904123	Ciba Corning Acs Hcg Immunoassay	Ciba Corning Diagnostics Corp.	JHI	Class II	1990-10-03
K904054	Polyviolene(tm) Suture	Look, Inc.	GAS	Class II	1990-10-03
K904011	Model #527 Ophthalmic Stretcher	Midmark Corp	FPO	Class II	1990-10-03
K903942	Shimadzu X-Ray High Voltage Generatpr Ahd150g	Shimadzu Medical Systems	IZO	Class I	1990-10-03
K903914	Paramax Cerebrospinal Fluid/urine Protein Blank	Baxter Healthcare Corporation	JGQ	Class II	1990-10-03
K903879	Ivac(r) Syringe Pump - Model 740	Y	FRN	Class II	1990-10-03
K903809	Protected Needle with or without IV Set	Kendall Mcgaw Laboratories, Inc.	FPA	Class II	1990-10-03
K903732	Kendall Safetrak(tm) High Flow Catheter	Kendall Healthcare Products Co. Div.Of Tyco Health	FOZ	Class II	1990-10-03
K903694	Amici Tru-Fit Soft Plastic Mouthpiece	Amici, Inc.	IYT	Class II	1990-10-03
K903084	Modular Cathcart Fracture System	Depuy, Inc.	LZY	Class II	1990-10-03
K902991	Icon Strep B Immunoenzymetric Assay	Hybritech, Inc.	GTY	Class I	1990-10-03
K902961	Dimension-II Total Hip System	Kirschner Medical Corp.	JDI	Class II	1990-10-03
K902943	Rsi Femoral Guiding Catheter	Retroperfusion Systems, Inc.	DQO	Class II	1990-10-03
K902940	Cardiolase Yag Model 4000 Surgical Laser System	Trimedyne, Inc.	GEX	Class II	1990-10-03
K902939	Optilase Yag Model 1000 Surgical Laser System	Trimedyne, Inc.	GEX	Class II	1990-10-03
K901901	Profile, a Critical Care Low Air Loss Bed	KCI USA, Inc.	FNM	Class II	1990-10-03
K900858	Candela Sptl-1 Laser for Treating Benign Vasc. Les	Candela Corporation	GEX	Class II	1990-10-03
K900051	Moore Type Endo Prosthesis	Lima Intl. Corp.	KWY	Class II	1990-10-03
K904346	Bauman Cpr/resuscitator	General Medical Products, Inc.	BTM	Class II	1990-10-02
K904136	Suture Tension Adjustment Reel	Surgical Systems, Inc.	KGS	Class I	1990-10-02
K904086	Discrene Self-Supporting Breast Form	MEDLINE INDUSTRIES, LP - Northfield	KCZ	Class I	1990-10-02
K904047	Accuprobe Coccidioides Immitis Culture Confirm.	Hologic, Inc.	MDF	Class II	1990-10-02
K903843	Immunodot Thyroid Autoimmunity Panel	General Biometrics, Inc.	JNL	Class II	1990-10-02
K903765	Quidel Chlamydia Positive Control	Ortho-Clinical Diagnostics, Inc.	LJC	Class I	1990-10-02
K903556	Accuprobe Cryptococcus Neoformans Culture Test	Hologic, Inc.	MDE	Class II	1990-10-02
K903435	Shiley Specialized Tracheostomy Tube	Shiley, Inc.	JOH	Class II	1990-10-02
K903302	Electrode, Electrosurgery	Megadyne Medical Products, Inc	JOS	Class II	1990-10-02
K903027	Pegasus with Accessories	Pfizer Laser Systems	GEX	Class II	1990-10-02
K902990	Coherent Holmium:yag Surgical Laser	Coherent Medical Division	GEX	Class II	1990-10-02
K902947	Pegasus W/accessories for Arthroscopic Application	Pfizer Laser Systems	GEX	Class II	1990-10-02
K902946	Pegasus W/accessories for General Surgery	Pfizer Laser Systems	GEX	Class II	1990-10-02
K902604	Blake Medical Breathing Tube Support	Blake Medical, Inc.	CBH	Class I	1990-10-02
K902595	Catarrhalis Test Strip	Remel Inc	JTO	Class I	1990-10-02
K902133	Model Is102s Nd:yag Surgical Laser System	Niic U.S.A., Inc.	GEX	Class II	1990-10-02
K896017	The Ophthimus System	Hightech Vision	DQK	Class II	1990-10-02
K895650	Enteral Pump Set W/entera-Flo Spike	Delmed, Inc.	KNT	Class II	1990-10-02
K895329	600Ml and 1200Ml Enteral Bag Adm. Set for Entera	Delmed, Inc.	KNT	Class II	1990-10-02
K895142	Enteral Pump Set with Enteral Spike	Delmed, Inc.	KNT	Class II	1990-10-02
K904312	Rheumagen Crp T-Control	Biokit USA, Inc.	DCK	Class II	1990-10-01
K904286	Scale-Tronix Incubator Scale Model:4050/modified	Scale-Tronix, Inc.	FRW	Class I	1990-10-01
K904048	Multi Drug Infusion System	Halyard Health	FRN	Class II	1990-10-01
K904013	Spive Needle System, Modification	Pascall Medical Corp.	FPA	Class II	1990-10-01