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 2118 of 3531

510(k) clearances, page 2118 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K946293	Mill-Rose Scope Cleaning Brush	Mill-Rose Laboratory	MNL	Class I	1995-02-16
K946073	Oralvue Dental Mirror	Hines Group, Ltd.	EAX	Class I	1995-02-16
K945997	Modified Fox Extra Gram Positive	Micro-Media Systems, Inc.	JWY	Class II	1995-02-16
K945671	Continuous Epidural Anesthesia Tray	Trinity Laboratories, Inc.	CAZ	Class II	1995-02-16
K945664	Barikare Plus	KCI USA, Inc.	FNL	Class II	1995-02-16
K945300	Accessory Item to Endosseous Dental Implant	O Co., Inc.	DZE	Class II	1995-02-16
K945258	Catco Urinary Collection Kit	Catco Medical, Inc.	FCN	Class II	1995-02-16
K944904	Parrallel Pin	O Co., Inc.	DZE	Class II	1995-02-16
K944847	Kultsure/starswab Anaerobic Transport System	Starplex Scientific Corp.	JSL	Class I	1995-02-16
K942842	Hewlett-Packard M1021a Mix Ven Oxy Sat Plug-in Module	Hewlett-Packard Co.	DQA	Class II	1995-02-16
K942113	Carbon Dioxide Analyzer (Model Cd-3A)	Ametek, Inc.	CCK	Class II	1995-02-16
K941628	40 Micron Blood Transfusion Filter	Douglas Medical Products, Inc	FPB	Class II	1995-02-16
K941543	Dial Medical Kit	Regulatory & Marketing Services, Inc.	KOC	Class II	1995-02-16
K941030	Dried Gram-Negative Cefpodoxime	Baxter Diagnostics, Inc.	LTT	Class II	1995-02-16
K935485	Fas Fastidious Mic Panel	Microtech Medical Systems, Inc.	JWY	Class II	1995-02-16
K933117	Iort System	Northwest Medical Physics Center	IYE	Class II	1995-02-16
K915691	Focus Rtp	Elekta Limited	MUJ	Class II	1995-02-16
K950037	N 800 HF	Oldelft Corp. of America	IZO	Class I	1995-02-15
K946262	Euro, Scst, Sccft Atlas Radiologic Tables	Scott Imaging Intl., Inc.	IXQ	Class II	1995-02-15
K946261	Mts-007, Sts-008, Ssmts-010, Euro-40, 72, Super Euro 4072, 5000	Scott Imaging Intl., Inc.	IYB	Class I	1995-02-15
K945749	Bennett X-Ray Tomography System	Bennett X-Ray Corp.	IZF	Class II	1995-02-15
K945731	Hfq High Frequency Radiographic and Fluroscopic Generators	Bennett X-Ray Corp.	IZO	Class I	1995-02-15
K945383	High Dose Rate Afterloader	Varian Assoc., Inc.	JAQ	Class II	1995-02-15
K944384	Orion's Urethral Catheterization Kit without Bag	Regulatory & Marketing Services, Inc.	FGM	Class I	1995-02-15
K944379	Orion's Foley Catheterization Kit with Catheter and Bag	Regulatory & Marketing Services, Inc.	FGM	Class I	1995-02-15
K944378	Orion's Urethral Catheterization Kit with Catheter and Bag	Regulatory & Marketing Services, Inc.	FGM	Class I	1995-02-15
K942490	Babe Computer Pogram for Obstetric Ultrasound	Medical Soft, Inc.	HEM	Class II	1995-02-15
K942423	Nais Wrist Blood Pressure Meter	King & Spalding	DXN	Class II	1995-02-15
K942422	Panasonic Wrist Blood Pressure Meter	King & Spalding	DXN	Class II	1995-02-15
K940412	Multileaf Intensity Modulating Collimator	Nomos Corp.	IXI	Class II	1995-02-15
K950322	Relaxy-the Wonder Hand	Kinsei Shiatsu, Inc.	ISA	Class I	1995-02-14
K950321	Shape Up Momi Roller	Kinsei Shiatsu, Inc.	ISA	Class I	1995-02-14
K950320	Relaxy-Wonder Knock	Kinsei Shiatsu, Inc.	ISA	Class I	1995-02-14
K946291	Elastyren(r) Patient Examination Gloves	Eci Medical Technologies, Inc.	LZA	Class I	1995-02-14
K946176	Storz Phacoemulsification Needles	Storz Instrument Co.	HQC	Class II	1995-02-14
K945738	Visiflex Ophthalmic Surgical Incise Drape	Visitec Co.	HMT	Class II	1995-02-14
K945516	Natural-Hip(tm) System - Calcar Replcement Stem	Intermedics Orthopedics	LZO	Class II	1995-02-14
K944885	Dh-1, Dh-2, Dh-3, Dh-6, Dh-68, Dh-8, Amh-6, Fm-10, Fm-20, Fm-30, Fbm-1000, Fbm-2000	Kolvin Industries, Ltd.	ISA	Class I	1995-02-14
K944884	Dr-3, Dr-6, Dr-68, Dr-88, Amr-6, Fr-22R, Dr-22B	Kolvin Industries, Ltd.	ISA	Class I	1995-02-14
K944730	Massager	North American Technical Services Corp.	ISA	Class I	1995-02-14
K944665	Dib Infusors	Novacon Corp.	MEB	Class II	1995-02-14
K944320	Vented/non-Vented Gemini Administration Set	Imed Corp.	FPA	Class II	1995-02-14
K944210	Arthroscope Accessories	Stryker Corp.	HRX	Class II	1995-02-14
K943521	Viotec 1400 Series Ultraviolet Germicidal Fixture	Schiff & Co.	FRA	Class II	1995-02-14
K943458	As/3 Airway Module	Datex Division Instrumentarium Corp.	CBS	Class II	1995-02-14
K942959	Kit Pak Wet Saline Dressing	Kit Pak, Inc.	FRO	Unclassified	1995-02-14
K942387	Selby Instrumentation	Advanced Spine Fixation Systems, Inc.	MNH	Class II	1995-02-14
K941717	Martinez Hydroxylapatite Orbital Implant	Miguel Martinez M.D.	HPZ	Class II	1995-02-14
K941470	Tracheostomy Care Kit	Clinical Resources, Inc.	BTO	Class II	1995-02-14
K940082	Thromboscreen Thromboplastin-Ds	Pacific Hemostasis	GJS	Class II	1995-02-14