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 2272 of 3531

510(k) clearances, page 2272 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K926368	Applicator Nozzle	Centrix, Inc.	EKJ	Class I	1993-09-15
K931973	Disposable Peel-Away Introducer Sheath	Neuro Navigational Corp.	GWG	Class II	1993-09-14
K931001	Oralix Dc	Gendex Corp.	EHD	Class II	1993-09-14
K926251	B-Scan Opthalmic Ultrasound Imaging System	Biovision, Inc.	IYO	Class II	1993-09-14
K925650	Imageview 5000	Nuclear Data Systems	LMC	Class II	1993-09-14
K925587	Nasal/oral Mask	Respironics, Inc.	BZD	Class II	1993-09-14
K933259	Scd(r) Controller	Kendall Healthcare Products Co. Div.Of Tyco Health	JOW	Class II	1993-09-13
K933201	Aesculap Trocar Instrument Set	Aesculap Inc	GCS	Class II	1993-09-13
K933104	One-Handed Endopouch Specimen Retrieval Bag	Ethicon, Inc	GCJ	Class II	1993-09-13
K932857	Abdominal Fluid Control Pouch, 203-301-S;etc.	Ansley Medical Products, Inc.	KKX	Class II	1993-09-13
K932793	Pulpdent 2.5% Nitric Acid Etchant	Pulpdent Corporation	EBF	Class II	1993-09-13
K932227	Amelogen Restorative Materials	Ultradent Products Inc.	EBF	Class II	1993-09-13
K932025	Ion-Implanted Neo Sentalloy	Gac Intl., Inc.	EJF	Class I	1993-09-13
K931827	Cleanlet, Cleanlet Xl & Kids	Gainor Medical Europe, Ltd.	FMK	Class II	1993-09-13
K930765	Ultra Compact Video Imager	International Imaging Electronics	JAK	Class II	1993-09-13
K930625	Sanitas Patient Lift	Dutton-Lainson Co.	FSA	Class I	1993-09-13
K930538	Acufex Suretac(r) Pac	Acufex Microsurgical, Inc.	JDR	Class II	1993-09-13
K925642	Zeiss Diode-Pumped Solid State Laser	Carl Zeiss, Inc.	GEX	Class II	1993-09-13
K925064	Relax-O-Guard	Aquatemp Service Co., Inc.	KMY	Class I	1993-09-13
K925012	Plastic Chain	American Orthodontics	EJF	Class I	1993-09-13
K924732	Porta Plumesafe(tm) 601 Smoke Evacuation System	Buffalo Filter Co., Inc.	FYD	Class II	1993-09-13
K924731	Plumesafe(tm) 1201 Smoke Evacuation System	Buffalo Filter Co., Inc.	FYD	Class II	1993-09-13
K923218	Nitanium Palatal Expander	Ortho Organizers Inc	EJF	Class I	1993-09-13
K920452	The Branemark System Ball Attachment Abutment Syst	Nobelpharma USA, Inc.	DZE	Class II	1993-09-13
K933557	Reference Material for Phencyclidine in Human Urine	Consolidated Technologies, Inc.	LAS	Class I	1993-09-10
K933244	Disposable Grasping Forcep	Neuro Navigational Corp.	GWG	Class II	1993-09-10
K933076	Aesculap Manual Endoscopic Instruments	Aesculap Inc	GCJ	Class II	1993-09-10
K933033	Guiding Catheter Hemostasis Valve Cap	Arrow Intl., Inc.	DQY	Class II	1993-09-10
K932743	Mefix(r) Adhesive Fabric for Dressing Fixation	Scott Health Care	KGX	Class I	1993-09-10
K932250	Vidas Digoxin (Dig)	Biomerieux Vitek, Inc.	KXT	Class II	1993-09-10
K931997	Hcg Midstream Pregnancy Test	Mizuho USA, Inc.	LCX	Class II	1993-09-10
K930606	Ps Medical Disposable Subcutaneous Cath Passer	Pudenz-Schulte Medical Research Corp.	GYK	Class I	1993-09-10
K924752	Freedom Oximeter/eeg Digital Interface	Pro-Tech, Inc.	DQA	Class II	1993-09-10
K922942	Pro-Scope Model # Ps-4000	Pro-Den Systems, Inc.	EIA	Class I	1993-09-10
K921901	Port Access Infusion Set	Kawasumi Laboratories Co., Ltd.	FRN	Class II	1993-09-10
K921571	1St Impression	Wykle Research, Inc.	ELW	Class II	1993-09-10
K933980	Hp M1465a Standard Airway Adapter	Hewlett-Packard Co.	CCK	Class II	1993-09-09
K933889	Personal Best Low Range	Healthscan Products, Inc.	BZH	Class II	1993-09-09
K933436	Frame, Spectacle	Aoyama Optical Co., Ltd.	HQZ	Class I	1993-09-09
K933313	Spectacle Frames	Serrao Optical Intl., Inc.	HQZ	Class I	1993-09-09
K933287	745 Glycomat	Drew Scientific, Ltd.	LCP	Class II	1993-09-09
K933216	Karl Storz Endoscopy-America, Inc.	Karl Storz Endoscopy-America, Inc.	FFS	Class II	1993-09-09
K933183	Scimed Viper	Scimed Life Systems, Inc.	LIT	Class II	1993-09-09
K933032	Laparoscopic Surgical Retractor	Advanced Surgical, Inc.	GCJ	Class II	1993-09-09
K932999	New Star, Tae Han Optical	J.B. Eyewear, Inc.	HQZ	Class I	1993-09-09
K932929	Hrv 4000Em	All-Tronics Medical Systems	DSH	Class II	1993-09-09
K932802	Spectacle Frame	Insight Optical Mfg. Co. of Florida, Inc.	HQZ	Class I	1993-09-09
K932792	Pulpdent Maleic Acid Etchants	Pulpdent Corporation	EBF	Class II	1993-09-09
K932417	Ferno Washington Incubator Transporter, Mod. 35-It	Ferno-Washington Inc	FPL	Class II	1993-09-09
K932260	Ferno-Washington Ambulance Cot, 93Es Squad-Mate	Ferno	FPO	Class II	1993-09-09