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 2230 of 3531

510(k) clearances, page 2230 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K934547	Mectra Trocar	Mectra Labs, Inc.	GCJ	Class II	1994-02-18
K934094	Stryker Laparoscopic Suction Irrigator	Stryker Corp.	GCJ	Class II	1994-02-18
K933649	Conmed ECG Patient Cables and Leadwires	Conmedcorp	DSA	Class II	1994-02-18
K933405	Cogent Light Illuminator 10010 Xenon Light Source	Cogent Light Technologies, Inc.	GCT	Class II	1994-02-18
K933018	Mrt-50Gp	Toshiba America Mri, Inc.	LNH	Class II	1994-02-18
K932673	Apex Spx Cardial	Elscint, Inc.	IYX	Class I	1994-02-18
K932371	Cemax Clinicalview(tm) Station And/or Software	Cemax, Inc.	LLZ	Class II	1994-02-18
K932244	Smt-100X/h and Smt-100X/x Magnetic Resonance Imaging System	Shimadzu Medical Systems	LNH	Class II	1994-02-18
K932230	Crystal Vision and Accessories	I.C. Medical, Inc.	FYD	Class II	1994-02-18
K932074	Medisystems Apheresis Needle with Guard	Medisystems Corp.	FIE	Class II	1994-02-18
K931410	Novus Image Archive System, Teleradiology System	Novus Technologies, Inc.	LMB	Class I	1994-02-18
K931325	Otoacoustic Emissions Unit Celesta 503	Madsen Electronics (Canada), Ltd.	EWO	Class II	1994-02-18
K930038	Cannula: Kahn, Jarco, Corson and Ratchet	Thomasville Medical Assoc.	LKF	Class II	1994-02-18
K925799	Ad/v A.5	Adaptive Video, Inc.	LMA	Class II	1994-02-18
K925499	Laproscopic/endoscopic Surgical Instruments	Lapsurg of America	GCJ	Class II	1994-02-18
K923848	Goosen Self-Lubricating Catheter	Goosen Enterprises, Inc.	EZD	Class II	1994-02-18
K923312	High Permeability Dialyer	Medivators Inc	KDI	Class II	1994-02-18
K923139	Hemocor Hp Hemoconcentrator Series	Medivators Inc	KDI	Class II	1994-02-18
K913728	Denver(r) Peritoneo-Subclavian Shunt	Denver Biomedicals, Inc.	KPM	Class II	1994-02-18
K940304	Nitro	Everest & Jennings, Inc.	IOR	Class I	1994-02-17
K940303	Record	Everest & Jennings, Inc.	IOR	Class I	1994-02-17
K940259	Sterile Trocar and 5.7Mm Sleeve	Phx Technologies Corp.	GCJ	Class II	1994-02-17
K940255	Hyperinflation Bag System	Nutec, Inc.	NHK	Class II	1994-02-17
K935981	Mlt-2	Med Labs, Inc.	ILQ	Class II	1994-02-17
K935491	Centurion Mogen Clamp/circumcision (Ster/non Ster)	Centurion Medical Products, LP	HFX	Class II	1994-02-17
K935457	Localization Wire or Marker - Surgical	Bip USA, Inc.	GDF	Class I	1994-02-17
K935446	Visual Healthshields	Yorktowne Optical Co., Inc.	HQY	Class I	1994-02-17
K935316	Parasafe(r) Fixative	Scientific Device Laboratory, Inc.	LKS	Class I	1994-02-17
K935238	Argyle Turkel Safety Paracentesis Procedure Tray	Sherwood Medical Co.	FRG	Class II	1994-02-17
K935096	Biolex Impregnated Wound Dressing	C.R. Bard Inc	MGQ	Unclassified	1994-02-17
K935086	Auto Suture Disposable Optical Trocar	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1994-02-17
K934985	Endoscopic High Frequency Monopolar Cord	Karl Storz Endoscopy-America, Inc.	GEI	Class II	1994-02-17
K934800	Conmed Selectone Surgical Instruments	Conmedcorp	GEI	Class II	1994-02-17
K934750	Yankauer with Connecting Tubing	Trinity Laboratories, Inc.	GCJ	Class II	1994-02-17
K934656	Conmed Conductive Adhesive Electrosurgical Grounding Pads	Conmedcorp	GEI	Class II	1994-02-17
K934553	Wheel-O-Vator	The National Wheel-O-Vator Co., Inc.	ING	Class II	1994-02-17
K934511	5,6,7,9,10,11&12Mm Blunt-Tipped Trocar Obturators	Phx Technologies Corp.	GCJ	Class II	1994-02-17
K934510	5,6,7,9,10,11,12Mm Blunt-Tip Trocar Obtur/thread	Phx Technologies Corp.	GCL	Class II	1994-02-17
K934508	Battery Pack# S1024nc	Portable Power Systems, Inc.	LDD	Class II	1994-02-17
K934439	Rechargeable Battery Pack for Critikon 8100 Vital Signs Monitor	Portable Power Systems, Inc.	DPS	Class II	1994-02-17
K934028	Sterile Dressing Change Tray	Surgipro, Inc.	LRO	Class II	1994-02-17
K934015	Recharge Replace Battery Pk Spacelabs 4045 Mon/defib	Portable Power Systems, Inc.	LDD	Class II	1994-02-17
K933370	Stool Transport/processor	Sage Products LLC	LKS	Class I	1994-02-17
K933218	Refractometric, Total Protein	Pyramid Biological Corp.	JJX	Class I	1994-02-17
K933112	Alphatec Compression and Reconstruction Plates	Alphatec Spine, Inc.	HRS	Class II	1994-02-17
K933065	Battery Pack# S1009la	Portable Power Systems, Inc.	DPS	Class II	1994-02-17
K932904	Windmere Wand Massager	Windmere Corp.	ISA	Class I	1994-02-17
K932823	Battery Pack# S1018la for Ivac 4000, 4200 Vital Check	Portable Power Systems, Inc.	DXN	Class II	1994-02-17
K932540	Laporascopic Surgical Instruments /General Use	Advanced Surgical, Inc.	GCJ	Class II	1994-02-17
K932071	i.v. Start Kit	Clinipad Corp.	FOZ	Class II	1994-02-17