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 2186 of 3531

510(k) clearances, page 2186 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K932115	Rowden Uterine Manipulator Injector and Rumi	Blairden Precision Instruments, Inc.	LKF	Class II	1994-06-24
K930200	Multi Dopplex II / Fetal Dopplex II	Huntleigh Healthcare Ltd.	KNG	Class II	1994-06-24
K930193	Philips Endo-Cavitary MRI Coil	Philips North America LLC	LNH	Class II	1994-06-24
K921942	Hysteroscope (and Accessories)	Optimed Technologies, Inc.	HIH	Class II	1994-06-24
K911620	Stovall Endometrial Brush	Cook Ob/Gyn	HFE	Class II	1994-06-24
K942584	Putman Stabilizer	J. Michael Putman, M.D., P.A.	GCJ	Class II	1994-06-23
K942553	Genesis	Burton Medical Products Corp.	FTD	Class II	1994-06-23
K942365	Boston VII	Polymer Technology Corp.	HQD	Class II	1994-06-23
K940975	C450/c400 Infant Incubators	Air-Shields, Inc.	FMZ	Class II	1994-06-23
K934536	Vinyl Examination Gloves (Non Sterile)	Arista Latindo Industrial, Ltd. P.T.	LYZ	Class I	1994-06-23
K930175	Cath Belt Pd Catheter and Transfer Set Holder	Tabex Industries, Inc.	FJS	Class II	1994-06-23
K926101	Phoenix Opti-Max Dent Impl W/plas-Spray Tita/hydro	Phoenix Dental, Inc.	DZE	Class II	1994-06-23
K942620	Feather-Touch Single-Stick Device	Ulster Scientific, Inc.	FMK	Class II	1994-06-22
K942618	Ankle Calf Exerciser	Prevent Products, Inc.	BXB	Class I	1994-06-22
K942595	Argelite Pf+	Argen Precious Metals, Inc.	EJT	Class II	1994-06-22
K942590	Argesol W	Argen Precious Metals, Inc.	EJT	Class II	1994-06-22
K942589	Argesol P	Argen Precious Metals, Inc.	EJT	Class II	1994-06-22
K942397	Theradapt Highchair/stroller Insert	Theradapt Products Inc.	INN	Class I	1994-06-22
K942218	Shiatsu Massager	Westminster International Co., Inc.	ISA	Class I	1994-06-22
K942136	M.a.g. Inc Pediatric Temperature Monitoring Circuits	Mag, Inc.	CAI	Class I	1994-06-22
K942135	M.a.g. Inc. Coaxial Circuits	Mag, Inc.	CAI	Class I	1994-06-22
K942134	M.a.g. Inc. Brealthing Bags	Mag, Inc.	CAI	Class I	1994-06-22
K942133	M.a.g. Inc. Custom Anesthesia Circuits	Mag, Inc.	CAI	Class I	1994-06-22
K942132	M.a.g. Inc. Hyperinflation System	Mag, Inc.	CAI	Class I	1994-06-22
K942131	M.a.g. Inc. Guedel Airways	Mag, Inc.	CAI	Class I	1994-06-22
K942130	M.a.g. Inc. Mapleson D Circuits	Mag, Inc.	CAI	Class I	1994-06-22
K942129	M.a.g Inc. Adult Temperature Monitoring Anesthesia Circuits	Mag, Inc.	CAI	Class I	1994-06-22
K942128	M.a.g. Inc. Adult Gas Sampling Circuits	Mag, Inc.	CAI	Class I	1994-06-22
K942127	M.a.g Inc. Pediatric Gas Sampling Circuits	Mag, Inc.	CAI	Class I	1994-06-22
K942126	M.a.g. Inc. Adult Anesthesia Breathing Circuit	Mag, Inc.	CAI	Class I	1994-06-22
K942125	Volume Ventilator	Mag, Inc.	CAI	Class I	1994-06-22
K942124	Gas Sampling Lines and Connectors Circuits	Mag, Inc.	CAI	Class I	1994-06-22
K942123	M.a.g. Inc. Ventilator Hoses	Mag, Inc.	CAI	Class I	1994-06-22
K942122	Pediatric Anesthesia Circuits	Mag, Inc.	CAI	Class I	1994-06-22
K942021	Mouth to Mouth Breather	Gam Industries, Inc.	CBP	Class II	1994-06-22
K941969	Endoplus	Wembley Rubber Products (M) Sdn Bhd	BTR	Class II	1994-06-22
K941625	Dw234 #29	Rms Div.	EJS	Class II	1994-06-22
K941493	Kendall Safetrak Combined Epidural/spinal Kit	Kendall Healthcare Products Co. Div.Of Tyco Health	CAZ	Class II	1994-06-22
K941426	Symbiosis Reusable Monopolar Electrosurgical Probe	Boston Scientific Corporation	GEI	Class II	1994-06-22
K941289	Pulse Oximeter	Bci Intl., Inc.	DQA	Class II	1994-06-22
K941137	Scimed Triguide Guiding Catheter	Scimed Life Systems, Inc.	DQY	Class II	1994-06-22
K940897	Ivac Needleless Infection Valve Administration Set	Y	FPA	Class II	1994-06-22
K940802	Zipprep Electrode	Aspect Medical Systems, Inc.	DRX	Class II	1994-06-22
K940704	Conmed Versa-Stim Interferential Electrode	Conmedcorp	GXY	Class II	1994-06-22
K940638	Provox(tm) Voice Prosthesis	Atos Medical AB	EWL	Class II	1994-06-22
K940621	Pro-Shiatsu Portable Massager	Westminster International Co., Inc.	ISA	Class I	1994-06-22
K936267	Comfit Pink Powdered Examination Gloves	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1994-06-22
K936265	Comfit Green Powdered Examination Gloves	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1994-06-22
K934668	Zest Implant Anchor Advanced Generation (Dental)	Zest Anchors LLC	DZE	Class II	1994-06-22
K933059	Artromot-E, Elbow / Artromot-S, Shoulder Cmp Mod.	Jace Systems, Inc.	BXB	Class I	1994-06-22