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 1838 of 3531

510(k) clearances, page 1838 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K974833	Ck-Nac Reagent	Intersect Systems, Inc.	CGS	Class II	1998-02-13
K974779	Abbott Alcyon(tm) 300 (without Ise Module) and 300I (with Ise Module) Analyzer	Abbott Medical	JJE	Class I	1998-02-13
K974444	Numastation	Numa, Inc.	KPS	Class II	1998-02-13
K974437	Expert-Xl Lateral Spine Bmd Acquisition and Analysis Software	Lunar Corp.	KGI	Class II	1998-02-13
K974367	Advantx Lcn, Advantx Lclp	GE Healthcare	IZI	Class II	1998-02-13
K974348	Algoplaque Film Extra Thin Hydrocolloid Dressing	Laboratoires Urgo	FRO	Unclassified	1998-02-13
K974345	Mitek Knotless Anchor	Mitek Products	MBI	Class II	1998-02-13
K974336	Cholangiograph Balloon Catheter by J-Lloyd Medical, Inc.	J-Lloyd Medical, Inc.	GCJ	Class II	1998-02-13
K974335	Embolectomy, Irrigation - Occlusion Balloon Catheter by J-Lloyd Medical, Inc.	J-Lloyd Medical, Inc.	DXE	Class II	1998-02-13
K974318	Healthcare Service and Supply Alp Alternating Leg Pressure Pump and Gaarments for the Limb	Healthcare Service and Supply	JOW	Class II	1998-02-13
K974316	Hydrofera Femoral Wick	Hydrofera, LLC.	EFQ	Unclassified	1998-02-13
K974307	Rtr-2000/Rtr-4000	Terarecon, Inc.	JAK	Class II	1998-02-13
K974299	Panacryl	Ethicon, Inc	GAM	Class II	1998-02-13
K974297	Galileo Disposable Hysteroscopes	Netoptix Corp.	HIH	Class II	1998-02-13
K973750	Stc Cannabinoids Micro-Plate Eia	OraSure Technologies, Inc.	LDJ	Class II	1998-02-13
K973459	Norland Body Composition Option for Norland Dexa Bone Densitometers	Norland Corp.	KGI	Class II	1998-02-13
K973395	Episcreen Oral Specimen Collection Device	Epitope, Inc.	PJD	Class II	1998-02-13
K973191	The Visualized Endotracheal Tube System or Vett System	PULMONX, Corp.	BTR	Class II	1998-02-13
K972423	Rusch Tracheofix-Set	Rusch Intl.	JOH	Class II	1998-02-13
K970229	Arrow Transseptal Super Arrow-Flex Percutaneous Set	Arrow Intl., Inc.	DYB	Class II	1998-02-13
K980316	Alkaline Phosphatase-Sl Assay Catalogue Number 309-10, 309-30	Sekisui Diagnostics P.E.I. Inc.	CJE	Class II	1998-02-12
K980205	San Diego Biotech Hcg Pregnancy Dipstick Test	San Diego Biotech	JHI	Class II	1998-02-12
K980180	2700 Sample Manager	Waters Corporation	JQW	Class I	1998-02-12
K980178	Oxyhemoglobin Control for Co-Oximetry	Bionostics, Inc.	JJY	Class I	1998-02-12
K980069	Vanishpoint Syringe	Retractable Technologies, Inc.	MEG	Class II	1998-02-12
K974894	Kromatica Color Changing Alginate	Matech, Inc.	ELW	Class II	1998-02-12
K974874	Bilirubin-Sl (Total) Assay	Diagnostic Chemicals, Ltd. (USA)	CIG	Class II	1998-02-12
K974829	Non-PVC Fluid Path Port Access Infusion Set (with and without Injection Set)	Kawasumi Laboratories Co., Ltd.	LJT	Class II	1998-02-12
K974712	Quikstrip One Step Barbiturate Test	Syntron Bioresearch, Inc.	DIS	Class II	1998-02-12
K974651	Abbott Axsym System	Abbott Medical	JJE	Class I	1998-02-12
K974645	Femassist Flexible	Insight Medical Corp.	MNG	Class I	1998-02-12
K974606	Randox Magnesium	Randox Laboratories, Limited	JGJ	Class I	1998-02-12
K974531	Snore-Ezzer	Snore - Ezzer	LRK	Class II	1998-02-12
K974362	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JWY	Class II	1998-02-12
K974349	Ohmeda-Ohio Care Plus Incubator	GE Healthcare	FMZ	Class II	1998-02-12
K974289	Epi-Union Plating System	Howmedica Corp.	HRS	Class II	1998-02-12
K974029	Acs Tobramycin	Chiron Diagnostics Corp.	LCR	Class II	1998-02-12
K972512	Smash Percutaneous Transluminal Angioplasty (Pta) Cardiovascular Devices Panel	Boston Scientific Corporation	LIT	Class II	1998-02-12
K974832	Powderfree Latex Examination Gloves	Servicom Services Sdn Bhd	LYY	Class I	1998-02-11
K974661	0.2 U Bacterial Filter	Sims Deltec, Inc.	FPB	Class II	1998-02-11
K974250	Versastat Multipolar Scissors and Cables	Pilling Weck, Inc.	GEI	Class II	1998-02-11
K973827	Kimberly-Clark Self-Seal Pouch for Low Temperature Sterilization	Kimberly-Clark Corporation	KCT	Class II	1998-02-11
K972856	Ultra-Fine Diathermy Loop and Coagulation Balls	Rocket Medical	KNF	Class II	1998-02-11
K972771	Phased Array Transducer - - Pvf -375Dt	Toshiba America Medical Systems, In.C	ITX	Class II	1998-02-11
K971206	Meridian St Femoral Stem and Vitalock Solid Back Shell W/ Peri-Apatite Coating	Howmedica Corp.	LPH	Class II	1998-02-11
K970358	Ensemble Central Station Monitor	Mennen Medical, Inc.	DSI	Class II	1998-02-11
K974811	Accurun(tm) 150 Hsv Igg Positive Control	Boston Biomedica, Inc.	JJX	Class I	1998-02-10
K974772	Ufi Gel C	Voco GmbH	EBI	Class II	1998-02-10
K974629	O.b. Applicator and Non-Applicator Tampons	Personal Products Co.	HEB	Class II	1998-02-10
K974622	Dental D	Micro Dental Laboratories	EHP	Class I	1998-02-10