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 1786 of 3531

510(k) clearances, page 1786 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K971616	Blood Pressure Measurement System(dspm-70)	Data Sciences Intl., Inc.	DQO	Class II	1998-11-04
K983621	Needle Guide	Remington Medical	IZH	Class II	1998-11-03
K983562	Mascot Md Hematology Analyzer/ Model Md 700	Cdc Technologies, Inc.	GKZ	Class II	1998-11-03
K983513	Vitros Immunodiagnostic Products Range Verifiers	Ortho-Clinical Diagnostics, Inc.	JJY	Class I	1998-11-03
K983394	Modification to Tielle Hydropolmer Dressing	Johnson & Johnson Medical, Div. of Ethicon, Inc.	MGP	Unclassified	1998-11-03
K983294	All-in-One Container Cat#'s 2B8114,2b8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117m 2B8122, 2B8132, 2B8142, 2B712	Baxter Healthcare Corporation	KPE	Class II	1998-11-03
K983247	Super Porcelain Addmate	Noritake Co., Inc.	EIH	Class II	1998-11-03
K983206	Small Vaginal/rectal Electrode	Empi	KPI	Class II	1998-11-03
K983178	Coamatic Heparin	Instrumentation Laboratory Co.	KFF	Class II	1998-11-03
K983101	Bardex I.c 4-Way Foley Catheter Model 1865Sixx Xx = 18,20,22,24	C.R. Bard Inc	MJC	Class II	1998-11-03
K982959	Medrad Quad C-Spine Coil, 1.5T Model, M64csc, 1.0T Model M42csc	Medrad, Inc.	LNH	Class II	1998-11-03
K982921	Medrad 0.5T, 1.0T & 1.5T Breast Coil, Models M21brc, M42bra, M64bra	Medrad, Inc.	MOS	Class II	1998-11-03
K982878	Earscan 3	Micro Audiometrics Corporation	EWO	Class II	1998-11-03
K982870	Epifilm Otologic Lamina	Xomed, Inc.	KHJ	Class II	1998-11-03
K982775	Bausch & Lomb Renu Multi-Purpose Solution	Bausch & Lomb Incorporated	LPN	Class II	1998-11-03
K982773	Quickset Liquid and Powder	Specialites Septodont	EMA	Class II	1998-11-03
K982769	Mitra Imaging Inc. Exhibit	Mitra Imaging, Inc.	LLZ	Class II	1998-11-03
K982748	Bi-Polar Cord Set 1.88 Tr, Bi-Polar Cord Set 1.83 Tr, Model #'S Sb223, Sb 224	New Deantronics Taiwan Ltd.	GEI	Class II	1998-11-03
K982454	BIPAP Vision Ventilatory Support	Respironics, Inc.	MNT	Class II	1998-11-03
K982016	Piper Ippb Model 2055	Vortran Medical Technology 1, Inc	NHJ	Class II	1998-11-03
K981950	Sysmex R-3500, Automated Reticculocyte Analyzer, Model R-3500	Sysmex Corporation	GKL	Class II	1998-11-03
K981886	Vrac High Dose Rate (Hdr) Remote Afterloading Catheter	Cook Inc.	JAQ	Class II	1998-11-03
K981845	Hawk Anaesthesia Induction Unit	Medical Industrial Equipment	BSZ	Class II	1998-11-03
K981772	Halolite Aad System	Medic-Aid, Ltd.	CAF	Class II	1998-11-03
K981691	Silicone Soft Reline	Harry J. Bosworth Co.	EBI	Class II	1998-11-03
K981666	2.5 Mm Lactosorb Screws	Zimmer GmbH	DZL	Class II	1998-11-03
K981378	Datex-Engstrom Light Monitor Models F-Lm1, F-Lmp1	Datex-Engstrom, Inc.	DRT	Class II	1998-11-03
K983619	Barchens Company Digital Pacifier Thermometer	Barchens Co.	FLL	Class II	1998-11-02
K983246	Pos-T-Vac (Ivp-600)	Pos-T-Vac, LLC	LKY	Class II	1998-11-02
K983245	Pos-T-Vac (Avp-1000)	Pos-T-Vac, LLC	LKY	Class II	1998-11-02
K983069	Philips Duo Diagnost	Philips North America LLC	OWB	Class II	1998-11-02
K982985	Citrex Hospital Spray Disinfectant	Caltech Industries, Inc.	LRJ	Class I	1998-11-02
K982932	Medrad Anterior Neck Coil, 1.5T & 1.0T Model Numbers M64anc and M42anc	Medrad, Inc.	LNH	Class II	1998-11-02
K982919	Medrad Quad T/l Coil (1.5T, 1.0T & 0.5T) Models M64tlc, M42tlc, M21tlc	Medrad, Inc.	MOS	Class II	1998-11-02
K982839	Cadd-Legacy Pca Ambulatory Infusion System, Model 6300	Sims Deltec, Inc.	MEA	Class II	1998-11-02
K982836	Cadd-Legacy Plus Ambulatory Infusion System	Sims Deltec, Inc.	FRN	Class II	1998-11-02
K982776	9303 Neonatal/adult Vital Signs Monitor	Cas Medical Systems, Inc.	DQA	Class II	1998-11-02
K982717	Somnoplasty System, Models S2, 1010/2010,2000/1000,1100,3000/30Xx/6000, 1200	Somnus Medical Technologies, Inc.	GEI	Class II	1998-11-02
K982713	Rt Desktop	Elekta Oncology Systems, Ltd.	IYE	Class II	1998-11-02
K982611	Uniject Latex Examination Gloves (Powder Free)	Uniject Gloves Pcl	LYY	Class I	1998-11-02
K981600	Latex Examination Gloves Bubble Gum Flavoured Pre-Powdered	Young Innovations, LLC dba Plak Smacker	LYY	Class I	1998-11-02
K980576	Varian Endometrial Applicator for Varisource Remote High Dose Rate Afterloader	Varian Medical Systems, Inc.	JAQ	Class II	1998-11-02
K983207	Synthetic Powder-Free Vinyl Patient Examination Gloves	Shijiazhuang Great Eagle Plastic Products Co., Ltd.	LYZ	Class I	1998-10-30
K983124	Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Cytology Procedural Kit	Mill-Rose Laboratory	EOQ	Class II	1998-10-30
K983122	Mill-Rose Laboratories Transbronchial Needle Aspiration (Tbna) Combination Cytology/histology Procedural Kit	Mill-Rose Laboratory	EOQ	Class II	1998-10-30
K983067	Fine-Ject	Henke Sass Wolf of America, Inc.	FMI	Class II	1998-10-30
K982766	Paste Opaque Ex-3	Noritake Co., Inc.	EIH	Class II	1998-10-30
K981371	Ltv 1000 Ventilator	Pulmonetic Systems, Inc.	CBK	Class II	1998-10-30
K981366	Static and Dynamic Compliance, a Respiratory Mechanics Option for the Vmax Series	Sensor Medics Corp.	BTY	Class II	1998-10-30
K981034	Silent Night II	Sleep Solutions, Inc.	MNR	Class II	1998-10-30