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 1794 of 3531

510(k) clearances, page 1794 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K981985	Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205, 33206 & 33209	Siemens Healthcare Diagnostics Inc.	DHX	Class II	1998-09-24
K981564	Air Techniques' Airdent II	Air Techniques, Inc.	KOJ	Class II	1998-09-24
K974572	Gen-Probe Accuprobe Group B Streptococcus Culture Identification Test 2820	Chugai Pharmaceuticals Co., Ltd.	MDK	Class I	1998-09-24
K983134	Nbil	Abbott Medical	MQM	Class I	1998-09-23
K982962	Xenon Light Source, Models Ls6180, Ls6035	Contec Medical Vision, Ltd.	GCT	Class II	1998-09-23
K982960	Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument	Medical Device Technologies, Inc.	KNW	Class II	1998-09-23
K982817	Ewc: ECG Cable and Leadwire Systems	Ewc	DSA	Class II	1998-09-23
K982427	Trex Tilt C-Arm/table Multipurpose Radiographic/fluoroscopic Positioning System, Trex Tilt-C	Trex Medical Corp.	OWB	Class II	1998-09-23
K982400	Steri-Oss' Improv Temporary Dental Cement	Steri-Oss, Inc.	EMA	Class II	1998-09-23
K982244	Mayfield Acciss Optical System	Ohio Medical Instrument Co., Inc.	HAW	Class II	1998-09-23
K981069	Ultra-Cover Pu-Transducer Cover	International Medical Products, Inc.	ITX	Class II	1998-09-23
K974899	Gambro Central Water Treatment System Cwp 100 - Wro H	Gambro Healthcare	FIP	Class II	1998-09-23
K983166	Elecsys Calcheck Myoglobin	Boehringer Mannheim Corp.	JJY	Class I	1998-09-22
K983114	Magnatek80	Magna Advanced Technologies, Inc.	CCK	Class II	1998-09-22
K983088	Instacine D-2000	Fidelity Medical, Inc.	LLZ	Class II	1998-09-22
K983017	Modification to System 83 Plus	Wassenburg Medical B.V.	NVE	Class II	1998-09-22
K982945	Dual Purpose Closed Catheter	Spirit Medical Systems, Inc.	BSY	Class I	1998-09-22
K982922	Vacutainer Brand Blood Collection Syringe	Becton Dickinson Vacutainer Systems	JKA	Class II	1998-09-22
K982869	Ascent System	Zimmer GmbH	JWH	Class II	1998-09-22
K982802	Bayer Advia 60 Hematology System (in Vitro Diagnostic System)	Bayer Corp.	GKZ	Class II	1998-09-22
K982800	Ecton Lynx Ultrasound System	Ecton, Inc.	IYO	Class II	1998-09-22
K982571	Ksea Flipptack	Karl Storz Endoscopy-America, Inc.	MBI	Class II	1998-09-22
K982565	Easy Trans Tip	Carl Schuh	KXO	Class II	1998-09-22
K982553	Osteo Compression Hip Screw System	Osteonics Corp.	HRS	Class II	1998-09-22
K982546	Phaser-2000	Diomedics, Inc.	ILY	Class II	1998-09-22
K982542	Stryker Ureteral Illuminator System III	Stryker Corp.	FCS	Class II	1998-09-22
K982475	Soft Tissue Augmentation Yube with Insertion Tool	Tissue Technologies, Inc.	FTL	Class II	1998-09-22
K982403	Brennen Biosynthetic Surgical Mesh Matrix	Brennen Medical, Inc.	PAG	Class II	1998-09-22
K982319	Caregraph	Siemens Medical Solutions USA, Inc.	JAA	Class II	1998-09-22
K982306	Polytube	Ferris Mfg. Corp.	MGQ	Unclassified	1998-09-22
K982305	Spline Dental Implant System-Temporary Abutment	Sulzer Calcitek, Inc.	DZE	Class II	1998-09-22
K982271	Wako Direct Ldl-C	FUJIFILM Healthcare Americas Corporation	MRR	Class I	1998-09-22
K982259	Chroma Zone Color Stain	Kuraray America, Inc.	EBF	Class II	1998-09-22
K982221	Premier Ap	American Imex	GZJ	Class II	1998-09-22
K982073	Anchor Laparoscopic Tissue Retrieval System	Anchor Products Co.	GCJ	Class II	1998-09-22
K982063	Alm Prismalix (Prx) Surgical Light	Alm Surgical Equipment, Inc.	FSY	Class II	1998-09-22
K981734	Vtec-Rpla Seiken	Denka Seiken'S	GNA	Class I	1998-09-22
K981260	Kiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000M	Clinical Innovations, LLC	HDB	Class II	1998-09-22
K980930	Fibra Sonics Ultrasonic Surgical Aspirator System, Model 2100 Ussta	Fibra Sonics, Inc.	LFL	Unclassified	1998-09-22
K980798	Biosign H. Pylori Wb-New One-Step Anti-H. Pylori Antibody Test	Princeton BioMeditech Corp.	LYR	Class I	1998-09-22
K980398	Kaplan Pendulaser 115 Surgical Laser with Optoscan II	Optomedic Medical Technologies, Ltd.	GEX	Class II	1998-09-22
K974685	Osteonics Polyethylene Acetabular Components	Osteonics Corp.	JDI	Class II	1998-09-22
K974244	Immunodot Mono-M Test	Genbio	LSE	Class I	1998-09-22
K974226	Immunodot Mono-G Test	Genbio	LSE	Class I	1998-09-22
K973725	Bionect Clear Hydrogel	Fidia Pharmaceutical Corp.	MGQ	Unclassified	1998-09-22
K973724	Bionect Hydrogel Spray	Fidia Pharmaceutical Corp.	MGQ	Unclassified	1998-09-22
K973722	Bionect Hydrogel Foam	Fidia Pharmaceutical Corp.	MGQ	Unclassified	1998-09-22
K973721	Bionect Hydrogel Gauze Pads	Fidia Pharmaceutical Corp.	MGQ	Unclassified	1998-09-22
K972309	Jm-102 Jaundice Meter	Air-Shields, Inc.	MQM	Class I	1998-09-22
K982767	Raichem Hdl-Cholesterol Direct Reagent, Hdl-Cholesterol Calibrator	Raichem	JIX	Class II	1998-09-21