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 2285 of 3531

510(k) clearances, page 2285 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K932576	Pediatric Temperature Monitoring Circuits	Med-Plastics Intl., Inc.	CAI	Class I	1993-07-22
K932575	Adult Temperature Monitoring Anesthesia Circuits	Med-Plastics Intl., Inc.	CAI	Class I	1993-07-22
K932561	Guedel Airways	Life Shield Healthcare Products, Inc.	BTR	Class II	1993-07-22
K932560	Volume Ventilators	Life Shield Healthcare Products, Inc.	BZO	Class I	1993-07-22
K932558	Adult Anesthesia Breathing Circuit	Life Shield Healthcare Products, Inc.	CAI	Class I	1993-07-22
K932557	Hyperinflation System	Life Shield Healthcare Products, Inc.	BZR	Class II	1993-07-22
K932497	Precision Med Products, Ltd. Adult Gas Sampling	Precision Med Products, Ltd.	CAI	Class I	1993-07-22
K932489	Pmp, Ltd. Adult Temp. Monitoring Anesthesia Cir.	Precision Med Products, Ltd.	CAI	Class I	1993-07-22
K932488	Pmp, Ltd. Pediatric Gas Sampling Circuits	Precision Med Products, Ltd.	CAI	Class I	1993-07-22
K932379	All-Bond(r) Jr.	Bisco, Inc.	KLE	Class II	1993-07-22
K932241	Economy Hi-Low Mat Tables/electric Models	Bailey Mfg. Co.	INQ	Class I	1993-07-22
K932239	Electric Tilt Table Model 9505	Bailey Mfg. Co.	INQ	Class I	1993-07-22
K932238	Eco. Hi-Low Treatment Tables Various Model Numbers	Bailey Mfg. Co.	INW	Class I	1993-07-22
K932237	Pro. Hi-Low Treatment Tables Models 4050,4070,4090	Bailey Mfg. Co.	INQ	Class I	1993-07-22
K932236	Pro. Hi-Low Table Model 9530	Bailey Mfg. Co.	INQ	Class I	1993-07-22
K932235	Pro. Hi-Low Mat Tables #9610-9612 9620-9622	Bailey Mfg. Co.	INQ	Class I	1993-07-22
K932234	Professional & Econmy Tilt Table 9500 9520	Bailey Mfg. Co.	INW	Class I	1993-07-22
K932233	Economy Hi-Low Work Table (Manual) Model 3405	Bailey Mfg. Co.	INW	Class I	1993-07-22
K932232	Professonal Hi-Low Work Table Model 3400	Bailey Mfg. Co.	INQ	Class I	1993-07-22
K932231	Economy Hi-Low Mat Table #4110 Thru 4117	Bailey Mfg. Co.	INW	Class I	1993-07-22
K932184	Sterile Lemaitre Glow 'N Tell Tape	Vascutech, Inc.	KFX	Class II	1993-07-22
K932112	Olympic Infa-Length	Olympic Medical Corp.	FTY	Class I	1993-07-22
K932065	Dlase 300 Upgrade	Incirt Tech., Inc.	GEX	Class II	1993-07-22
K932002	Baritone C2, Modification	Confi-Dental Products Co.	EBC	Class II	1993-07-22
K931890	Glucose-Hk Test	Em Diagnostic Systems, Inc.	CFR	Class II	1993-07-22
K931870	Bonding Resin Product Line	Ultradent Products Inc.	KLE	Class II	1993-07-22
K931869	Ultraseal Xt Pit and Fissure Sealant Product Line	Ultradent Products Inc.	EBC	Class II	1993-07-22
K931868	Primadry Product Line	Ultradent Products Inc.	EBC	Class II	1993-07-22
K931857	Supplemental Formula to Baritone L3 Sealant	Confi-Dental Products Co.	EBC	Class II	1993-07-22
K931813	Needlesafe Handguard	Adrian Anesthesia Systems, Inc.	FPA	Class II	1993-07-22
K931793	Symbiosis ENT Surgical Instruments	Boston Scientific Corporation	LRC	Class I	1993-07-22
K931774	Upgraded Package for Dlase 300 Pulsed Dental Laser	Sunrise Technologies, Inc.	GEX	Class II	1993-07-22
K931751	Zero Gravity Wheelchair	General Components Intl., Inc.	IOR	Class I	1993-07-22
K931705	Endoscopic Instrument Holder	Mayaguez Medical Center	GCJ	Class II	1993-07-22
K931502	Vivaglass Liner	Ivoclar North America, Inc.	EJK	Class II	1993-07-22
K931462	Glenroe Chain	Glenroe Technologies	ECI	Class I	1993-07-22
K931349	Tmr-670	Pride Health Care, Inc.	INO	Class II	1993-07-22
K931309	Variolink	Ivoclar North America, Inc.	EBF	Class II	1993-07-22
K931294	Iq Tuptake Assay	Becton Dickinson Advanced Diagnostics	KHQ	Class II	1993-07-22
K930900	Cook Aspiration Unit	Cook Ob/Gyn	JCX	Class II	1993-07-22
K930730	Dormie Neck Support System	The Western Diagnostics Co.	IQK	Class I	1993-07-22
K930698	The Model 3003 Scaler	Dentsply Intl.	ELC	Class II	1993-07-22
K930691	Accutrac Traction Unit	I-Rep, Inc.	ITH	Class II	1993-07-22
K930568	Adair/veress Needle Introducer Set	Medical Dynamics, Inc.	GCB	Class I	1993-07-22
K930462	Endoscopic Umbrella Retractor	Surgical Technologies, Inc.	GCJ	Class II	1993-07-22
K930439	Marco Surgiscope Operation Microscopes	Marco Ophthalmic, Inc.	HRM	Class I	1993-07-22
K926547	Mednext 1000 Bone Dissecting System	Mednext, Inc.	HSZ	Class I	1993-07-22
K926470	Laser and Emphasis Sclerostomy Tip	Summit Technology, Inc.	HQF	Class II	1993-07-22
K926391	Accuflex Dynamic Elbow Orthosis	Regulatory & Marketing Services, Inc.	IQI	Class I	1993-07-22
K926307	Peak Flow Meter	Monaghan Medical Corp.	BZH	Class II	1993-07-22