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 1872 of 3531

510(k) clearances, page 1872 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K971093	Opportunity i.v. Start Kit	Opportunity, Inc.	MGP	Unclassified	1997-09-16
K971091	Oppurtunity Tracheostomy Care Kit	Opportunity, Inc.	KMF	Class I	1997-09-16
K971090	Opportunity Dressing Change Tray	Opportunity, Inc.	KMF	Class I	1997-09-16
K971089	Opportunity, Inc. Laceration Tray	Opportunity, Inc.	KKX	Class II	1997-09-16
K971088	Opportunity Incision and Drainage Tray	Opportunity, Inc.	EFQ	Unclassified	1997-09-16
K971046	Handiflex	Handiflex Corp.	JFB	Class II	1997-09-16
K963865	8 Fr. -30Cc Narrowflex Sheathless Intra-Aortic Balloon Catheter, Product Number Iab-04830S	Arrow Intl., Inc.	DSP	Class II	1997-09-16
K973044	Disetronic H-Tron Plus V 100 Insulin Infusion Pump	Disetronic Medical Systems	LZG	Class II	1997-09-15
K972592	2T Prestige(100-6321-0107)/Privilege(100-6326-0102)/Gyrex V-Ep(100-6327-0101)	Elscint, Inc.	MOS	Class II	1997-09-15
K972312	Siemens Orthophos Ds/ds Ceph	Siemens Corp.	EHD	Class II	1997-09-15
K972296	Magnetic Resonance Diagnostic System	GE Healthcare	MOS	Class II	1997-09-15
K972264	First Midcath Catheter	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	1997-09-15
K972263	First Picc Catheter with Dual Lumens	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	1997-09-15
K972262	First Picc Catheter	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	1997-09-15
K972261	Rivetti-Levinson Instraluminal Shunt	Integra Neurocare, LLC	DWF	Class II	1997-09-15
K971315	Auxiliary Instruments for Urs	Richard Wolf Medical Instruments Corp.	FCL	Class I	1997-09-15
K963926	Axsym Ca 15-3	Abbott Medical	MOI	Class II	1997-09-15
K973388	Dentin Conditioning and Adhesive (Bond 1)	Jeneric/Pentron, Inc.	KLE	Class II	1997-09-12
K973202	Modification of Opus Ferritin Test System	Behring Diagnostics, Inc.	DBF	Class II	1997-09-12
K973133	Big Bag 3000 Pressure Infusor	Byron Medical	FRN	Class II	1997-09-12
K973102	Lidocaine Eia Assay	Diagnostic Reagents, Inc.	KLR	Class II	1997-09-12
K973072	Wako Nefa Linearity Set	FUJIFILM Healthcare Americas Corporation	JJX	Class I	1997-09-12
K972475	Auradapt Aubtment System	Nobel Biocare Uas, Inc.	NHA	Class II	1997-09-12
K972306	Powderfree Colored and Flavored Nitrile Copolymer Patient Examination Gloves-Medical Device	P.T. Irama Dinamika Latex	LZA	Class I	1997-09-12
K972289	Midas Rex Motor	Midas Rex Pneumatic Tools, Inc.	HBB	Class II	1997-09-12
K972256	Fcr Fuji Computed Radiography Dms Crt Image Console Hi-C654 (for Networks)	FUJIFILM Healthcare Americas Corporation	LLZ	Class II	1997-09-12
K972254	First Midcath Catheter	Becton Dickinson Infusion Therapy Systems Inc.	FOZ	Class II	1997-09-12
K972249	Orthophos Plus and Orthophos Plus/cd	KaVo Dental Technologies, LLC	EHD	Class II	1997-09-12
K972248	Nellcor Puritan Bennett Gemini	Medtronic, Inc.	CBK	Class II	1997-09-12
K972009	Pure Advantage Nitrile Hypoallergenic Surgical Glove	Tillotson Healthcare Corp.	KGO	Class I	1997-09-12
K971762	Belleglass Hp Enamel Repair Material	Sybron Dental Specialties, Inc.	EBF	Class II	1997-09-12
K971727	Dci Water Purifier	Dental Components, Inc.	EIA	Class I	1997-09-12
K971594	Flow-Rite	Pulpdent Corporation	EBF	Class II	1997-09-12
K970544	Depuy Dupont Orthopaedics Finger Joint Prosthesis	Depuy, Inc.	KYJ	Class II	1997-09-12
K963711	Baby Dopplex (3000)	Huntleigh Healthcare Ltd.	HGM	Class II	1997-09-12
K960884	Tele Trens Tm 10	Life Sensing Instrument Company, Inc.	DSI	Class II	1997-09-12
K972666	Tandem-Mp Ostase Immunoenzymetric Assay	Hybritech, Inc.	CIN	Class II	1997-09-11
K972644	Breath-So-Fresh Tongue Cleaner	Intl. Dental Design Specialists, Inc.	LCN	Class I	1997-09-11
K972479	Alta Plating System	Howmedica Corp.	HRS	Class II	1997-09-11
K972442	Ceiling Mounted Lateral Positioner, Model No. 6896.002	Continental X-Ray Corp.	JAA	Class II	1997-09-11
K972435	Ultima and Ultima Lx Cemented Femoral Stem	Johnson & Johnson Professionals, Inc.	JDI	Class II	1997-09-11
K972407	Root Apex Locator	Toei Electric Co., Ltd.	LQY	Unclassified	1997-09-11
K972380	Kodak Digital Science (Kds) Medical Image and Information Library (Miil)	Eastman Kodak Company	LMB	Class I	1997-09-11
K972320	Bioz System & Bioz Portable	Cardiodynamics International Corp.	DSB	Class II	1997-09-11
K972285	Gettig Styrl-Ject Delivery System	Gettig Pharmaceutical Instrument Co.	EJI	Class II	1997-09-11
K971869	Finesse All-Ceramic System	Dentsply Intl.	EIH	Class II	1997-09-11
K970817	Micromark Clip	Biopsys Medical, Inc.	GDW	Class II	1997-09-11
K965160	Hp Orvue Intra-Op (M2510a)	Hewlett-Packard Co.	BSZ	Class II	1997-09-11
K964755	Microjet Cavity Preparation System	Midwest Dental Products Corp.	KOJ	Class II	1997-09-11
K964624	Siemens Sc9000/sc9015 Bedside Monitoring System	Siemens Medical Solutions USA, Inc.	DSI	Class II	1997-09-11