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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2598 of 3530

510(k) clearances, page 2598 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K893122	Heated Servo Humidifier, Model Hds 2	Lifetronics, Inc.	BTT	Class II	1989-10-20
K892124	Impla-Med Implant System	Impla-Med	DZE	Class II	1989-10-20
K891458	Sw 803 Low Frequency Stimulator Dana Touch	Back in Action, Inc.	IPF	Class II	1989-10-20
K891301	Patient Examination Gloves (Latex)	Taiping Leasing Corp. Sdn. Bhd.	LYY	Class I	1989-10-20
K882270	Models 27040 & 27050 Conti. Flow Resectoscopes	Karl Storz Endoscopy-America, Inc.	HIH	Class II	1989-10-20
K895861	Delta-Tech(tm) Cast Removal System	Johnson & Johnson Professionals, Inc.	LGH	Class I	1989-10-19
K895840	Milenia(tm) Total T4 (Mkt41,5)	Siemens Healthcare Diagnostics Inc.	CDP	Class II	1989-10-19
K895757	Irri-Evacuator	Mikro-Tek Laboratories	GBX	Class I	1989-10-19
K895718	Lithium Concentrate for a Flame Photometer	Data Medical Associates, Inc.	JGM	Class II	1989-10-19
K895606	Exusorb(tm) Gel Dressing	Controlled Therapeutics Corp.	KMF	Class I	1989-10-19
K895453	Spinal Needle	Advance Medical Designs Inc	BSP	Class II	1989-10-19
K895407	Cortisol Clasp-Bead Eia Kit	Biotecx Laboratories, Inc.	CGR	Class II	1989-10-19
K895395	V. Mueller Rhoton Self-Retaining Brain Retractor	Baxter Healthcare Corporation	GZT	Class II	1989-10-19
K895357	Anethesia Breathing Circuit	F.L.W. Plastics, Inc.	CAI	Class I	1989-10-19
K895144	Intertech Metered Dose Elbow	Intertech/Ohio	BZA	Class I	1989-10-19
K895138	Clinistat Ldh Reagent Test	Kulzer GmbH	CFH	Class II	1989-10-19
K894854	Qct Bone Mineral Density Analysis Software	Image Enhancements	KGI	Class II	1989-10-19
K894667	Models Pb950 and Pb960 Dataloop and Spiroloop	Pneumedics, Inc.	BTY	Class II	1989-10-19
K894642	Sleepap Mask	Medical Industries America, Inc.	BYG	Class I	1989-10-19
K894632	Model Ssh-140A Ultrasound Imaging System	Toshiba America Medical Systems, In.C	DXK	Class II	1989-10-19
K893394	Orthopedic Wound Drainage Set with Trocar	Haemonetics Corporation	CAC	Class II	1989-10-19
K892712	Mip/ct Image Processing Workstation	Kontron Electronics	LLZ	Class II	1989-10-19
K892644	Biolox Ceramic Ball	Allo Pro Corp.	LZO	Class II	1989-10-19
K890981	Electro-Touch (Et) Glove	Psychoenergetic Systems, Inc.	GXY	Class II	1989-10-19
K895986	Precision Dental Attachments	Implant Support Systems, Inc.	EGG	Class I	1989-10-18
K895897	Manan Prostatic Biopsy Needle	Argon Medical Devices, Inc	FCG	Class II	1989-10-18
K895762	Canula Suction for Surgical General and Plastic	Kolster Methods	GEA	Class I	1989-10-18
K895761	General Asperator	Kolster Methods	JCX	Class II	1989-10-18
K895203	En-Trap Syringe	The Medtech Group, Inc.	FMF	Class II	1989-10-18
K894750	Biostix I. Hcg - One Step Pregnancy Test	Princeton Biomedix	JHI	Class II	1989-10-18
K894705	Biospot Hcg-Rapid Pregnancy Test	Princeton Biomedix	JHI	Class II	1989-10-18
K894704	2.5 French Lithotriptor Electrode	Northgate Research, Inc.	FFK	Class II	1989-10-18
K894071	Comfort Sheer Firm and Sheer Support Pantyhose	Sara Lee Corp.	DWL	Class II	1989-10-18
K893962	Cobe 2991 Supplementary Disposable Sets	Cobe Laboratories, Inc.	LKN	Unclassified	1989-10-18
K882386	Agar 3K Neuromuscular Stimulator	Solcoor, Inc.	IPF	Class II	1989-10-18
K895872	Lan.0800q/2800q	Amersham Corp.	DBF	Class II	1989-10-17
K895808	Technicon Dpa-1(Tm) System Serum Albumin	Technicon Instruments Corp.	DCF	Class II	1989-10-17
K895752	Diamond Blade Surgical Knives	Magnum Diamond, Inc.	GDM	Class I	1989-10-17
K895643	Modified Uropump* Fluid Management System	Orthoconcept, Inc.	FDC	Class II	1989-10-17
K895496	Beta2 M-Trac by Enzyme Bead-Based Immunoassay Eia	Incstar Corp.	JZG	Class II	1989-10-17
K895380	Sr1 Prolactin (Prl Immunoenzymetric Assay	Serono-Baker Diagnostics, Inc.	CFT	Class I	1989-10-17
K895338	Anti-Rnp and Anti-Sm Antibody Test	Immco Diagnostics, Inc.	LKO	Class II	1989-10-17
K895313	Microlite Ml 1000 (Model 3) Microplate Luminometer	Dynatech Laboratories, Inc.	JJQ	Class I	1989-10-17
K895285	Mentor Ductal Catheters	Mentor	GBZ	Class I	1989-10-17
K895119	Systemate Direct Bilirubin Catalog No. 65406	Em Diagnostic Systems, Inc.	CIG	Class II	1989-10-17
K895118	Systemate Total Bilirubin Catalog No. 65407	Em Diagnostic Systems, Inc.	CIG	Class II	1989-10-17
K895047	Clinistat Potassium Reagent Test	Kulzer GmbH	CFM	Class I	1989-10-17
K894934	Hycor Sentry Drugs of Abuse Urine Calibrators	Hycor Biomedical	DKB	Class II	1989-10-17
K894902	Sourcerer	Oakfield Instruments, Ltd.	JJJ	Class I	1989-10-17
K894684	Pti Intra-Art Internal Mammary Artery Cannula Kit	Pioneering Technologies, Inc.	DWF	Class II	1989-10-17