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 1955 of 3531

510(k) clearances, page 1955 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K963286	Immage Immunochemistry System Haptoglobin (Hpt) Reagent	Beckman Instruments, Inc.	DAD	Class II	1996-10-07
K963036	Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse Blood	Becton Dickinson Microbiology Systems	JTZ	Class II	1996-10-07
K963015	Surgical Staple Marker Device (Modify)	Biopsys Medical, Inc.	GDW	Class II	1996-10-07
K962956	Medi-Jector Choice Needle-Free Insulin Delivery System	Medi-Ject Corp.	KZE	Class II	1996-10-07
K962909	Dental Prep Wash and Prep Disinfect	William J. Day	EBF	Class II	1996-10-07
K962849	Catheter Insertion Tray	Medcare Medical Group, Inc.	LJS	Class II	1996-10-07
K962812	Gluma Desensitizer/gluma 3 Primer	Kulzer GmbH	KLE	Class II	1996-10-07
K962763	2000 Modular Thirty-Nine	Equi-Tron Mfg., Inc.	FNL	Class II	1996-10-07
K962739	T.b.q.	Convatec, A Division of E.R. Squibb & Sons	LRJ	Class I	1996-10-07
K962709	Sigma Syringe Delivery System(multi-Doser Rev. 1/Multi-Doser Rev. Ii/single-Doser Rev. 1-10/Single-Doser Rev. 1-20/	Sigma Intl.	FRN	Class II	1996-10-07
K962667	Capiox Sx25 Hollow Fiber Oxygenator with Detachable Hardshell Reservoir	Terumo Medical Corp.	DTZ	Class II	1996-10-07
K962647	Angled Abutment	Straumann USA, LLC	DZE	Class II	1996-10-07
K962411	Ontrak Testcup Amphetamines	Roche Diagnostic Systems, Inc.	DKZ	Class II	1996-10-07
K962286	2505 Face Mask, Tie String / Anti-Fog / Face Shield	Berkley Medical Resources, Inc.	FXX	Class II	1996-10-07
K962146	Excel Onestep Group a Strep Antigen Module Test Kit	Excel Scientific, Inc.	GTZ	Class I	1996-10-07
K961602	Latex Patient Examination Glove (Pink)	Siam Sempermed Corp., Ltd.	LYY	Class I	1996-10-07
K961415	Latex Patient Examination Glove (Blue) (Modification)	Siam Sempermed Corp., Ltd.	LYY	Class I	1996-10-07
K955627	Vidas Chlamydia Blocking Assay	Biomerieux Vitek, Inc.	LJC	Class I	1996-10-07
K963377	Eos Brand Disposable Vaginal Speculum-Eosspec	North Eos Industries, Inc.	HIB	Class II	1996-10-04
K963355	Solopak Paragon Infusor Pump and Infusion Set	Solopak Medical Products, Inc.	MEB	Class II	1996-10-04
K962897	Eg-3400, Video Gastroscope	Pentax Precision Instrument Corp.	FDS	Class II	1996-10-04
K962681	Ecogel 300 TENS Gel	Eco-Med Pharmaceuticals, Inc.	GYB	Class II	1996-10-04
K962676	Disposable Endoscopic Retrieval Device	United States Endoscopy Group, Inc.	FGO	Class II	1996-10-04
K962663	Solopak Sidekick Infusion Pump and Administation Set	Solopak Medical Products, Inc.	MEB	Class II	1996-10-04
K962652	Urinary Drainage Bag, (Reorder No. 0749 - Product No. 900-749)	Customed, Inc	KNX	Class II	1996-10-04
K962173	Shikey Tracheostomy Tubes and Accessories	Mallinckrodt Medical	JOH	Class II	1996-10-04
K961821	Aspect Medical Systems Zipprep EEG Sensor	Aspect Medical Systems, Inc.	GXY	Class II	1996-10-04
K961664	Compat Nasojejunal Feeding Tube	Sandoz Nutrition	KNT	Class II	1996-10-04
K955685	Rns Sterile, Disposable CT Biopsy Tray	Contour Fabricators of Florida, Inc.	DXT	Class II	1996-10-04
K962824	Implantech Jej Peri-Pyriform Implant	Implantech Associates Inc	FZE	Class II	1996-10-03
K962769	Horizon Hip System	Biologically Oriented Prostheses	LPH	Class II	1996-10-03
K962639	Impra Carboflo Eptfe Vascular Graft	Impra, Inc.	DSY	Class II	1996-10-03
K962624	Resolut Regenerative Material	W. L. Gore & Associates, Inc.	LYC	Class II	1996-10-03
K962233	Twist-Off Screw	Landos, Inc.	HWC	Class II	1996-10-03
K961094	Mitek Threaded Anchor (Modification)	Mitek Products	MBI	Class II	1996-10-03
K961091	Karl Storz Model 203020 20 Equimat	Karl Storz Endoscopy-America, Inc.	HIG	Class II	1996-10-03
K960425	Buechel-Pappas Polyethlene Acetabular Component(01-42-Yyxx & 01-43-Yyxx	Endotec, Inc.	JDI	Class II	1996-10-03
K955596	N Latex B2-Microglobulin Reagent	Behring Diagnostics, Inc.	JZG	Class II	1996-10-03
K954490	Mercury Medical CPR Bag Exhalation Filter	Mercury Medical	CAH	Class II	1996-10-03
K963217	Anchorlok II Soft Tissue Anchor System	Wrightmedicaltechnologyinc	MBI	Class II	1996-10-02
K963200	Questus Polyester Suture Soft Tissue Anchor System	Wrightmedicaltechnologyinc	MBI	Class II	1996-10-02
K963185	Electronic X-Ray Timer 1400A, 1400Aw and Universal Digital Dental X-Ray Timer	Electronic Control Concepts	EHD	Class II	1996-10-02
K963113	Flexiflo Polyg Gastostomy Tube	Abbott Medical	KNT	Class II	1996-10-02
K962837	Nulife	Med-Tech Rubber & Engineering Industries	KGO	Class I	1996-10-02
K962784	Ultium Spinal Plating System	Smith & Nephew, Inc., Orthopaedic Div.	MNH	Class II	1996-10-02
K962745	Enteric Pathogen Transport (Ept) (E1020,e1000)	Prepared Media Laboratory, Inc.	JSN	Class I	1996-10-02
K962626	Patient Protective Limb	Kenad SG Medical, Inc.	FMQ	Class I	1996-10-02
K962278	Superstand Stand-Up Whellchair	The Standing Company	IPL	Class II	1996-10-02
K961000	Capiox Sx18 Hollow Fiber Oxygenator with and without Detachable Hardshell Reservoir	Terumo Medical Corp.	DTZ	Class II	1996-10-02
K960811	Phacoscope	Saint John'S Plaza Medical Group	HQC	Class II	1996-10-02