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 2122 of 3531

510(k) clearances, page 2122 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K944664	Wako Micro-Albumin B/wako Micro Albumin Calibrator	FUJIFILM Healthcare Americas Corporation	JIQ	Class I	1995-02-07
K944509	Dexide Insufflation Tubing with Filter	Dexide, Inc.	HIF	Class II	1995-02-07
K944391	Om-4 (Tenative) Urodynamic Measruement System	Surgitek	FEN	Class II	1995-02-07
K944013	CT Prospeed Family	GE Healthcare	JAK	Class II	1995-02-07
K943879	Resectoscope Electro Cautery Cutting Loop	American Urologicals, Inc.	FAS	Class II	1995-02-07
K942993	Thermoresin Lc II	GC America Inc.	EBF	Class II	1995-02-07
K942671	CPR Shield	Rondex Products, Inc.	CBP	Class II	1995-02-07
K942457	Graft Thrombectomy Instruments	Intramed Laboratories, Inc.	MCW	Class II	1995-02-07
K942184	Clinitron at Home Air Fluided Therapy	Ssi Medical Services, Inc.	INX	Class II	1995-02-07
K942052	Lifesign Mi Myoglobin	Princeton Biomedix	DDR	Class II	1995-02-07
K934884	Model 2231 CO2 Insufflator	Richard Wolf Medical Instruments Corp.	HIF	Class II	1995-02-07
K930628	Klaas IOL Lensfolder	Bova Intl.	KYB	Class I	1995-02-07
K950214	Abdominal Wall Retractor	Omni-Tract Surgical, Div. Minn. Scientific, Inc.	GCJ	Class II	1995-02-06
K946330	Karl Stortz Pivot Arm Laparoscope Sleeve, Endo-Retractor	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1995-02-06
K946292	Bioderm Medical Composite Wound Dressing	Bioderm, Inc.	MGP	Unclassified	1995-02-06
K945458	Vacutainer Brand Safety-Gard Phlebotomy System	BD Becton Dickinson Vacutainer Systems Preanalytic	GIM	Class II	1995-02-06
K942923	Ceres 900C & Ceres Uv900c	Bio-Tek Instruments, Inc.	JJQ	Class I	1995-02-06
K940430	Sedratrol	Medical Specialties Intl., Inc.	GJR	Class II	1995-02-06
K940297	Universal Wrist	Turnkey Intergration USA, Inc.	JWI	Class II	1995-02-06
K935789	Posterior Stabilized Apollo Knee System	Intermedics Orthopedics	JWH	Class II	1995-02-06
K931286	Slt Multidimensional Contact Laser System	Surgical Laser Technologies, Inc.	GEX	Class II	1995-02-06
K950286	Symbiosis Bipolar Scissors	Boston Scientific Corporation	GCJ	Class II	1995-02-03
K950030	Heliodent Md	KaVo Dental Technologies, LLC	EAP	Class II	1995-02-03
K946143	Chemspex(tm) Ammonia Control	Clinical Controls, Inc.	JJX	Class I	1995-02-03
K946058	60 Fundus Camera Cf-60Uv	Canon Medical Components U.S.A., Inc.	HKI	Class II	1995-02-03
K945725	Phenytion Eia Test	Diagnostic Reagents, Inc.	DIP	Class II	1995-02-03
K945705	5F Envoy(tm) Guiding Catheter	Cordis Neurovascular, Inc.	DQY	Class II	1995-02-03
K945572	Codman(r) Ridig and Steerable Endoscope Holder, Model 83-1352	Johnson & Johnson Professionals, Inc.	GWG	Class II	1995-02-03
K945463	Pendant Mount Narkomed 2C Anesthesiua System	Draeger, Inc.	BSZ	Class II	1995-02-03
K945461	Piton(tm) Y-Pack and Piton(tm) Tri-Pack)	Medtronics Interventional Vascular	DTL	Class II	1995-02-03
K945236	Aims Cannulated Acl Screw (7Mm Diameter)	Smith and Nephew Donjoy, Inc.	HWC	Class II	1995-02-03
K945164	Multiple	Protection Gloves Sdn. Bhd.	LYY	Class I	1995-02-03
K944998	Calibration Gas	Sunox, Inc.	BXK	Class I	1995-02-03
K944732	Dexter Isokinetic	Cedaron Medical, Inc.	IKK	Class II	1995-02-03
K944344	Lung Technologies 5000 Therapeutic Incentive Spirometer	Lung Technologies, Inc.	BWF	Class II	1995-02-03
K944227	Electra 1400C Automatic Coagulation Analyzer	Medical Laboratory Automation Systems, Inc.	GKP	Class II	1995-02-03
K944212	Radias Red Cell Folate Immunoasay	Bio-Rad	CGN	Class II	1995-02-03
K943895	Vision System Colonscope	Cogentix Medical, Inc.	FDF	Class II	1995-02-03
K943894	Sysmex K-4500	Sysmex Corporation	GKZ	Class II	1995-02-03
K943868	Scipotex	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1995-02-03
K943566	Ultimax Powder Free Surgical Gloves (Unbeaded)	Wembley Rubber Products (M) Sdn Bhd	KGO	Class I	1995-02-03
K943545	Ceiling Suspended C-Arm Support Mh-100	Shimadzu Medical Systems	IZI	Class II	1995-02-03
K943303	Pvk-357At	Toshiba America Medical Systems, In.C	IYO	Class II	1995-02-03
K943301	Quik Combo	Physio Control, Inc.	DRX	Class II	1995-02-03
K942545	Sigma Elite	Penlon, Ltd.	CAD	Class II	1995-02-03
K942511	Scipotex Powder Free Exam Gloves (Beaded)	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1995-02-03
K941928	Various Electrodes	Bio-Logic Systems Corp.	GWN	Class II	1995-02-03
K941799	Disposable Cutaneous Electrodes	Bio-Logic Systems Corp.	GXY	Class II	1995-02-03
K941459	Gram Positive Dried Overnight Panels/lomeflox	Baxter Diagnostics, Inc.	JWY	Class II	1995-02-03
K940920	Road Savage	Redman, Inc.	ITI	Class II	1995-02-03