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 2316 of 3531

510(k) clearances, page 2316 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K923591	Pala-Nate	Gesco Intl., Inc.	BTR	Class II	1993-03-16
K923573	Duracon Metal Backed Patella	Howmedica Corp.	JWH	Class II	1993-03-16
K922682	Americana Hip Prothesis	Osteo Technology, Inc.	JDG	Class II	1993-03-16
K920066	Palco Labs Model 340 Pulse Oximeter	Palco Laboratories, Inc.	DQA	Class II	1993-03-16
K930486	Quanta Lite(tm) Thyroid T Elisa	Inova Diagnostics, Inc.	DDC	Class II	1993-03-15
K930082	Endoscope and Accessories	Weck Endoscopy	GCJ	Class II	1993-03-15
K926258	Dlx	GE Healthcare	IZI	Class II	1993-03-15
K926118	Life Trace(r) Bilirubin Mask	Graphic Controls Corp.	FOK	Class I	1993-03-15
K925929	Rstar Intensive Care Unit Mini-Pacs(icu Mini-Pacs)	Rstar, Inc.	LMD	Class I	1993-03-15
K924764	Overtube for Endscopic Ligator	Superior Healthcare Group, Inc.	MNK	Class I	1993-03-15
K924265	Doctor's Choice Latex Examination Gloves	Chesire Laboratories	LYY	Class I	1993-03-15
K923982	Olympus Oes Laparoscopy System	Olympus Corp.	GCJ	Class II	1993-03-15
K922469	Pro-Lok Extension Set(s)	VLV Associates, Inc.	FPA	Class II	1993-03-15
K922100	Disposable Turp Fluid Containment Drape - Sterile	Graham Medical Products	EJJ	Class II	1993-03-15
K925893	Oem Medical Adult Anesthesia Breathing Circuit	Oem Medical Div.	CAI	Class I	1993-03-12
K925604	Ortho(tm) Recombiplastin W/ortho Diluent	Ortho Diagnostic Systems, Inc.	GJS	Class II	1993-03-12
K924233	Savacare Latex Examination Gloves	Preventive Care, Inc.	LYY	Class I	1993-03-12
K923532	National Screening Institute Micro-Plate Tsh Assay	Solarcare Technologies Corp,Inc.	JLW	Class II	1993-03-12
K922788	Bioaction Low Profile Screw System	Orthopaedic Biosystems, Ltd.	HWC	Class II	1993-03-12
K922482	Microscan Dri Gram Posit/gram Nega Mic/combo Panel	Baxter Diagnostics, Inc.	LRG	Class II	1993-03-12
K922471	Sarns Retrograde Cannula - Auto Inflate	3M Health Care, Sarns	DWF	Class II	1993-03-12
K920618	Autotransfusion Suction Set	Lifestream Int'L, Inc.	CAC	Class II	1993-03-12
K915308	Peg Gastrostomy Tube Kit	Sandoz Nutrition	FPD	Class II	1993-03-12
K930760	Med-Plastics Intl., Inc. Breathing Filter	Med-Plastics Intl., Inc.	CAH	Class II	1993-03-11
K930429	Aid, Cardiopulmonary Resuscitation	Valley Forge Scientific Corp.	BTM	Class II	1993-03-11
K926018	Crystal Enteric/nonfermenter Id System	Becton Dickinson Microbiology Systems	JSS	Class I	1993-03-11
K926017	Crystal Rapid Stool/enteric Id System	Becton Dickinson Microbiology Systems	JSS	Class I	1993-03-11
K924814	Api 20E/uniscept 20E	Analytical Products, Inc.	JSS	Class I	1993-03-11
K924122	Variant Beta-Thalassemia Short Program	Bio-Rad	JPD	Class II	1993-03-11
K923817	Ultragold	J.F. Jelenko & Co., Inc.	EJT	Class II	1993-03-11
K923209	Medgraphics Exercise Consult	Medical Graphics Corp.	BZM	Class II	1993-03-11
K921649	Retriever 10	Target Therapeutics	DQO	Class II	1993-03-11
K921387	Bird 8400St Adult Volume Ventilator	Bird Products Corp.	CBK	Class II	1993-03-11
K913766	Ansell No Powder Ambi Patient Examination Gloves	Ansell, Inc.	LYY	Class I	1993-03-11
K930621	Tina-Quant Crp	Boehringer Mannheim Corp.	DCK	Class II	1993-03-10
K930421	Elias Dsdna ABS	Elias U.S.A., Inc.	DHC	Class II	1993-03-10
K930247	Human a-Ds DNA Eia Kit for Diagnostic Use	The Binding Site	DHC	Class II	1993-03-10
K930162	Aca Digoxin Analytical Test Pack	E.I. Dupont de Nemours & Co., Inc.	KXT	Class II	1993-03-10
K924535	Thayer Hand Held M.k.i. Holding Chamber	Thayer Medical Corportation	CAF	Class II	1993-03-10
K924127	Dantec Evolution	Dantec Medical, Inc.	GWF	Class II	1993-03-10
K924083	700/700-1	Citicare Systems, Inc.	CCK	Class II	1993-03-10
K924082	Philips Tomoscan Sr7000 CT Systems	Philips North America LLC	JAK	Class II	1993-03-10
K923894	Yhe Galileo Pleiade Electroencephalograph	Biosound, Inc.	GWQ	Class II	1993-03-10
K926282	Mckernan-Potts Grasping Forceps	Aslan Medical Technologies, Ltd.	GCJ	Class II	1993-03-09
K926281	Mckernan-Adson Aggressive Forceps	Aslan Medical Technologies, Ltd.	GCJ	Class II	1993-03-09
K925666	Therapacer 3000	Kvm Technologies, Inc.	BXB	Class I	1993-03-09
K925549	Slase 210 Plus Holmium Laser System	Sunrise Technologies, Inc.	GEX	Class II	1993-03-09
K925258	Dynamic Pressure Monitor 2000M and 2000C	Pin Dot Products, Inc.	JFC	Class I	1993-03-09
K925052	Qa Pressure Measurement System	Gabel Medical Instruments, Ltd.	JFC	Class I	1993-03-09
K924940	Femoral & Tibial Augment Block	Joint Medical Products Corp.	JWH	Class II	1993-03-09