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 2120 of 3531

510(k) clearances, page 2120 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945531	Blade Electrode	E & M Engineering, Inc.	GEI	Class II	1995-02-10
K945514	Lifesign(tm) 1, Biosign(tm) 1, Lifesign Plus(tm), Lifesign(tm) Hcg	Princeton BioMeditech Corp.	LCX	Class II	1995-02-10
K945080	Quickvue in-Line One-Step Strep a Control Swabs (Positive & Negative Swab Specimens)	Ortho-Clinical Diagnostics, Inc.	GTY	Class I	1995-02-10
K944922	Alko Cal Packs for Corning 654 Analyzers	Alko Diagnostic Corp.	JIX	Class II	1995-02-10
K944911	Ace Iron Reagent	Schiapparelli Biosystems, Inc.	JIY	Class I	1995-02-10
K944214	Baxter Handle Model 1150	Baxter Edwards	DTJ	Class I	1995-02-10
K943897	Nu-Site	Medex, Inc.	FPA	Class II	1995-02-10
K943859	Quick Checker Hcg Pregnancy Test	Mizuho USA, Inc.	JHI	Class II	1995-02-10
K943597	Monarch Ap(tm)	Merit Medical Systems, Inc.	MAV	Class II	1995-02-10
K942850	Zoll Powerbase(tm)	ZOLL Medical Corporation	MKJ	Class III	1995-02-10
K941780	Orthovita Biogran	DSM Biomedical, Inc.	LYC	Class II	1995-02-10
K941610	Clensicair Low Airloss Hydrotherapy	Support Systems Intl.	IOQ	Class II	1995-02-10
K935184	Redifurl and Teperseal Dl Intra-Aortic Balloon Catheters with Hydromer Coating	Abbott Medical	DSP	Class II	1995-02-10
K932950	Tina-Quant Microalbumin	Boehringer Mannheim Corp.	JIR	Class I	1995-02-10
K932932	Snoremaster Snore Remedy	The Snoremaster Co.	LQZ	Class II	1995-02-10
K950378	Argus Laparoscopy Instrument System	Argus Medical Co., Inc.	GCJ	Class II	1995-02-09
K950198	Manual Surgical Instrument for General Use	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1995-02-09
K950036	Olympus 5Fr Semi-Rigid Scissors for Ob/gyn	OLYMPUS Corporation of the Americas	HIH	Class II	1995-02-09
K946195	Summit Mechanical Wheelchair	Summit Durable Medical Equipment, Inc.	IOR	Class I	1995-02-09
K946148	Karl Stors Knives, Curettes, Hooks, Needles	Karl Storz Endoscopy-America, Inc.	EOB	Class II	1995-02-09
K945682	Processor, Radiographic-Film, Automatic, Dental	Gendex Corp.	EGY	Class II	1995-02-09
K945603	Cordless Massager with Heat ( Various Brand Names)	Headwaters, Inc.	IRO	Class I	1995-02-09
K945495	4-Channel Urodynamic Monitor with Uro-Flo Option	Fiberoptic Sensor Technlogies, Inc.	EXY	Class II	1995-02-09
K945397	Angio II	Philips North America LLC	LNH	Class II	1995-02-09
K945330	Allevyn Adhesive	Smith & Nephew United, Inc.	KMF	Class I	1995-02-09
K945067	Ebice	Electro-Biology, Inc.	ILO	Class II	1995-02-09
K944862	Karl Storz Insulated Dissecting Cannulae, Cannulae, Suction Tubes	Karl Storz Endoscopy-America, Inc.	KNF	Class II	1995-02-09
K944447	Cool/heat Therapy Applicator	Medical Science Technology, Inc.	ILO	Class II	1995-02-09
K944155	Playtex Ultimates Silk Glide Tampons #23094	Playtex Products, Inc.	HEB	Class II	1995-02-09
K944154	Playtex Ultimates Silk Glide Tampons #22994	Playtex Products, Inc.	HEB	Class II	1995-02-09
K944064	Playtex Ultimates Silk Glide Tampons #22894	Playtex, Inc.	HEB	Class II	1995-02-09
K943844	Totally Cool(tm) Tc-1	Electro Science Technologies, Inc.	ILO	Class II	1995-02-09
K943819	Isola Anterior System	Acromed Corp.	KWQ	Class II	1995-02-09
K943250	Liberty	Utah Medical Products, Inc	KPI	Class II	1995-02-09
K943109	Remote Control Radioisotope Applicator	Inter-Pal GmbH	JAQ	Class II	1995-02-09
K942882	Totally Cool(tm) Tc-2	Electro Science Technologies, Inc.	ILO	Class II	1995-02-09
K942751	Vanguard Series Gas Regulators	Buckman Co., Inc.	CAN	Class I	1995-02-09
K942737	Poet Iq with Five Agent Capability	Criticare Systems, Inc.	CBS	Class II	1995-02-09
K942580	Neoprobe 1000 Portable Radioisotope Detector and Accessories	Neoprobe Corp.	IZD	Class I	1995-02-09
K941927	The Nomos Crane	Nomos Corp.	JAI	Class II	1995-02-09
K941029	Ogden Anchor-Small (Tentative)	American Medical Electronics, Inc.	JDR	Class II	1995-02-09
K941013	Hmt Alexcope	Servicetrends, Inc.	FGB	Class II	1995-02-09
K940445	Vivalink AED Defibrillator	Survivalink Corp.	MKJ	Class III	1995-02-09
K935160	Minimuffs	Bio-Logic Systems Corp.	EWE	Unclassified	1995-02-09
K934867	Acufex Tag Anchor	Acufex Microsurgical, Inc.	JDR	Class II	1995-02-09
K932690	Exactech Cruciate Retaining Cemented Total Knee Sy	Exactech, Inc.	JWH	Class II	1995-02-09
K950319	Resound(r) Personal Hearing System Ed-3 Encore	Resound Corp.	ESD	Class I	1995-02-08
K950317	Advantx 1824 Spotfilm Device	GE Healthcare	IXL	Class II	1995-02-08
K950080	Vip	Bell Hearing Instruments, Inc.	ESD	Class I	1995-02-08
K946244	Access(tm) Compass Bed	Toshiba America Mri, Inc.	LNH	Class II	1995-02-08