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 2051 of 3531

510(k) clearances, page 2051 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K952831	Bioscrew Absorbable Interference Screw	Linvatec Corporation	HWC	Class II	1995-09-15
K952825	Cuff Guard	Bowen Medical Services, Inc.	DXQ	Class II	1995-09-15
K952794	Harvard 2 Syringe Pump	Harvard Apparatus, Inc.	FRN	Class II	1995-09-15
K952783	Oxboro-Medical Pin Covers	Oxboro Medical Intl., Inc.	LRN	Class II	1995-09-15
K952739	Orthonail	Orthologic Corp.	HSB	Class II	1995-09-15
K952729	Painted Wedge & Rod Breast Board	Medtec LLC	IYE	Class II	1995-09-15
K952652	Medscand Endorette Endometrial Sampler	Medscand (USA), Inc.	HHK	Class II	1995-09-15
K952605	Suction/irrigator Tubing Kit	Surgical Laser Technologies, Inc.	GAZ	Class II	1995-09-15
K952520	Cardiolipin Igg,m,a Eia Test Kit	Immunoprobe, Inc.	MID	Class II	1995-09-15
K952342	Gambro Lundia 94-700 & Sigma 800 Hemodialyzers	Cobe Renal Care, Inc.	KDI	Class II	1995-09-15
K952282	Roche Ammonia/ethanol/co2 Calibrator	Roche Diagnostic Systems, Inc.	JIX	Class II	1995-09-15
K952242	Transfeer Spike II	The Medi-Dose Group	FPA	Class II	1995-09-15
K951110	Cardio Serv	Hellige GmbH	LDD	Class II	1995-09-15
K951029	Hamex One	Northern Orthopaedic Products, Inc.	BXB	Class I	1995-09-15
K950607	Ust-5268P-5 Transducer	Aloka Co., Ltd.	KRK	Class II	1995-09-15
K950582	Sullivan Passover Humidifer	Rescare, Ltd.	BTT	Class II	1995-09-15
K950440	Dual Function Pacing Wedge Pressure Balloon Catheter by J-Lloyd	J-Lloyd Medical, Inc.	DQO	Class II	1995-09-15
K950383	Apolipoprotein a-I Immunoturbidimetric Kit	Randox Laboratories, Limited	JHN	Class I	1995-09-15
K950382	Apolipoprotein B Immunoturbidiemetric Kit	Randox Laboratories, Limited	JHN	Class I	1995-09-15
K950279	Tomtecp90	TOMTEC Imaging Systems GmbH	LMB	Class I	1995-09-15
K950066	Dental Implant Endosseous	O Co., Inc.	DZE	Class II	1995-09-15
K950044	Fukuda Denshi Model Hc-300 End Tidal CO2 Module	Fukuda Denshi USA, Inc.	CCK	Class II	1995-09-15
K946220	Conmed Vcare (Vaginal-Cervical Ahluqalia's Retractor-Elevator) Retractor/elevator	Conmedcorp	LKF	Class II	1995-09-15
K946077	Directional Control Valves Inflatable Balloon-Type and Controllers	Hans Rudolph, Inc.	BZC	Class II	1995-09-15
K945733	Aquahab, Model 120-72-101	Aquarius Electronics, Inc.	BXB	Class I	1995-09-15
K945286	The Bagnoli-2 EMG System	Delsys Inc.	HCC	Class II	1995-09-15
K945216	Aes, (Anesco Evacuation System) Active Waste Anesthetic Gas Evacuation System	Anesco	CBN	Class II	1995-09-15
K944238	Endocyte Tm	D.L. Nelson and Assoc., Inc.	HCY	Class I	1995-09-15
K944200	Hi-Q Hand Instruments, Ob/gyn Use	OLYMPUS Corporation of the Americas	HET	Class II	1995-09-15
K944032	Video Scope System (Laryngoscope)	JEDMED Instrument Company	ENZ	Class II	1995-09-15
K940093	Ebv-Ea(d) Igg Elisa Test	Gull Laboratories, Inc.	LSE	Class I	1995-09-15
K934327	Arthrex Suture Anchor Screw System	Arthrex GmbH	MBI	Class II	1995-09-15
K954122	Take-Apart Scissors	Karl Storz Endoscopy-America, Inc.	GEI	Class II	1995-09-14
K953810	Fluff Gauze Bandage, Sterile & Non-Sterile	K. W. Griffen Co.	EFQ	Unclassified	1995-09-14
K953576	Storz Dp4505 Vitreous Membrane Dissector	Storz Instrument Co.	HQE	Class II	1995-09-14
K953575	Storz Mvs-3201 Vitrectomy Probe Pack	Storz Instrument Co.	HQE	Class II	1995-09-14
K953494	Tapertip Multisue Holmium Arthroscopic Handpiece, Various Endfiring Models, with/out a Sterilizable Instrument Tray	Trimedyne, Inc.	GEX	Class II	1995-09-14
K953432	Rotating, Fixed Footed, Fixed Shield Attachments, Dissecting Tools	Midas Rex Pneumatic Tools, Inc.	GET	Class I	1995-09-14
K953088	Triangular Sponges	Medical Perspectives Corp.	GDY	Class I	1995-09-14
K953087	Cherry Pit Dissector	Medical Perspectives Corp.	GDY	Class I	1995-09-14
K953062	Cherry Dissector	Medical Perspectives Corp.	GDY	Class I	1995-09-14
K953060	Rosebud Dissector	Medical Perspectives Corp.	GDY	Class I	1995-09-14
K953059	Kittner Dissector	Medical Perspectives Corp.	GDY	Class I	1995-09-14
K953058	Round Stick Sponges, Flat Stick Sponges	Medical Perspectives Corp.	GDY	Class I	1995-09-14
K953057	Cylindrical Sponge	Medical Perspectives Corp.	GDY	Class I	1995-09-14
K952755	Powersculptor Probes	Cardiogenes	GEX	Class II	1995-09-14
K951482	Endoscopes, Fiber Optic Laparoscopes, (Sterilizable)	Micro Medical Devices, Inc.	GCJ	Class II	1995-09-14
K951079	Nidek Model Gyc-1500 and Gyc-2000	Nidek, Inc.	HQF	Class II	1995-09-14
K946174	Block(tm) Arthroscopic Tool Kit	Johnson	HRX	Class II	1995-09-14
K953783	Conveen Leg Bag Strap	MEDLINE INDUSTRIES, LP - Northfield	FAQ	Class I	1995-09-13