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 2142 of 3531

510(k) clearances, page 2142 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K944649	Mill-Rose Harrell Bronchial Brush	Mill-Rose Laboratory	EOQ	Class II	1994-11-30
K944606	Cx Opiate Reagent for Synchron Cx Systems	Beckman-Diagnostic Systems Group	DJG	Class II	1994-11-30
K944381	Orion All Silicone Foley Catheter Temperature Probe	Regulatory & Marketing Services, Inc.	EZL	Class II	1994-11-30
K944380	Orion Foley Catheter	Regulatory & Marketing Services, Inc.	EZL	Class II	1994-11-30
K944376	Orion All Silicone Elastomer Coated Catheter	Regulatory & Marketing Services, Inc.	EZL	Class II	1994-11-30
K944361	Document R Ammonia/ethanol Control	Casco Standards	JJX	Class I	1994-11-30
K944337	Various Stethoscopes	Rud Riester GmbH & CO KG	LDE	Class I	1994-11-30
K944254	Oktas Stereo Viewing System	Oktas	FET	Class II	1994-11-30
K944244	Model E278or-Asp Series Retractable	Medtronic, Inc.	GEI	Class II	1994-11-30
K944087	Cx(tm) Cocaine Metabolite(cocm) Reagent/synchron Cx Sys	Beckman Instruments, Inc.	DIO	Class II	1994-11-30
K944028	Prochem Chemistry Analyzer	Prisma Systems	JJE	Class I	1994-11-30
K943726	Acoustic Recorder	Technology Applications Assoc., Inc.	DQC	Class I	1994-11-30
K943707	Latex Examination Gloves	Arista Latindo Industrial, Ltd. P.T.	LYY	Class I	1994-11-30
K943622	Schneider Pink Power Softip Guidnig Catheter	Boston Scientific Corporation	DQY	Class II	1994-11-30
K943540	Surgical Cutting Burs	Stryker Corp.	DZJ	Class II	1994-11-30
K943499	Kultsure Starswab(m240), Modification	Ncs Diagnostics, Inc.	JSM	Class I	1994-11-30
K943498	Kultsure Starswab (M210), Modification	Ncs Diagnostics, Inc.	JSM	Class I	1994-11-30
K942947	Comfit Examination Gloves, Powder Free, Hypoallergenic	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1994-11-30
K942338	Olympus Pf-8P Oes Pancreato Fiberscope and Accessories	Olympus Corp.	FDT	Class II	1994-11-30
K941488	Devmed Double-Balloon Urological Catheter	Medical Technology Development Corp.	EZL	Class II	1994-11-30
K940302	Arbo Monitring Safety Cable & Lead Wire Systems/arbo Unsheilded Safety Cable & Lead System	Arbo Medical, Inc.	DSA	Class II	1994-11-30
K940079	Arrow Percutaneous Sheath Introducer Kit Ak-07903	Arrow Intl., Inc.	DYB	Class II	1994-11-30
K936309	Deluxe Magmag Breast Pump	Pigeon Corp.	HGX	Class II	1994-11-30
K936181	Midmark M-11 Ultraclave Steam Sterilizer	Midmark Corp	FLE	Class II	1994-11-30
K931065	Laparoview	Northgate Technologies Inc.	HET	Class II	1994-11-30
K930771	Perfecta Total Hip System Coated Cocr Femoral Stem	Orthomet, Inc.	JDI	Class II	1994-11-30
K924502	Reusable Menstrual Pad	Keema and Co.	HHD	Class I	1994-11-30
K915750	Disposable Bacterial Breathng Filter	Hospitak, Inc.	CAH	Class II	1994-11-30
K945543	Gamgro Engstrom Y Filter with Edith Flex (1500 F), Edit 500, 1000, 2600 and Y Filter Packaged Alone	Intersect Medical Products, Inc.	CAH	Class II	1994-11-29
K945485	Abg Needle Protection	Devon Industries, Inc.	CBT	Class I	1994-11-29
K945255	Microsil	Microsonic, Inc.	ESD	Class I	1994-11-29
K944983	Medrad Counterpoise System	Medrad, Inc.	JAK	Class II	1994-11-29
K944790	Flexible Laparoscopic Cholangiography Catheter	Applied Medical Resources Corp	GBZ	Class I	1994-11-29
K944535	Prima, Inc. Gas Sampling Lines and Connectors	Prima, Inc.	BZA	Class I	1994-11-29
K944534	Prima, Inc. Connectors and Airway Extensions	Prima, Inc.	BZA	Class I	1994-11-29
K944533	Prima, Inc. Adult Anesthesia Circuit	Prima, Inc.	CAI	Class I	1994-11-29
K944468	Kerlix Zinc Saline Dressing	Kendall Healthcare Products Co. Div.Of Tyco Health	KMF	Class I	1994-11-29
K944427	Carrasyn Fdg	Carrington Laboratories, Inc.	MGQ	Unclassified	1994-11-29
K944416	Life	Sybron Dental Specialties, Inc.	EJK	Class II	1994-11-29
K944286	Metal-Lined Transcend Ceramic Bracket	Unitek Corp.	DYW	Class II	1994-11-29
K944201	Hi-Q Hand Instruments- Urology	OLYMPUS Corporation of the Americas	GCJ	Class II	1994-11-29
K944162	Denar Accuceph Cephalometer Imaging System	Teledyne Water Pik	EAG	Class II	1994-11-29
K943320	Head and Neck Coil for the Gyrex 2T-Dlx	Elscint, Inc.	LNH	Class II	1994-11-29
K942649	Minimus I; Minimus III, Sanaphon	Rud Riester GmbH & CO KG	DXN	Class II	1994-11-29
K941490	Blood Pressure Meter Model No. Bpm888	Integrated Display Technology, Ltd.	DXN	Class II	1994-11-29
K941244	Safeline System Turn Lock Cannula	Mcgaw, Inc.	FPA	Class II	1994-11-29
K941223	Advance Analysis Software	General Electric Co.	KPS	Class II	1994-11-29
K933845	Wilson-Cook Balloon Inflation Device	Wilson-Cook Medical Inc.	KNQ	Class II	1994-11-29
K945457	Trocar ( Accesory)	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1994-11-28
K945430	Dermavblade(tm)	Hasting'S Biomedical Corp.	MDM	Class I	1994-11-28