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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2962 of 3529

510(k) clearances, page 2962 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K853131	Thoro/cath Straight Thoracic Right Angle	J. H. Emerson Co.	GBS	Class I	1985-09-05
K852944	Fleximatic Massager	General Physiotherapy, Inc.	ISA	Class I	1985-09-05
K852913	Hgm Endocoagulator Model 20	Hgm, Inc.			1985-09-05
K852699	Freeman Acetabular Cup	Advanced Biosearch Assn.	KWA	Class III	1985-09-05
K852545	Band-Aid Brand Adhesive Bandages	Johnson & Johnson Professionals, Inc.	FRO	Unclassified	1985-09-05
K852495	Cast-Tech Co. Cooling System	Cast-Tech Co.	ILO	Class II	1985-09-05
K852413	Lgt Tube	Mallinckrodt Critical Care	BTO	Class II	1985-09-05
K852389	Ureteral Stent	American Medical Systems, Inc.	FAD	Class II	1985-09-05
K852170	Ezx Yellow, Blue or Orange	Strong Marketing	EGZ	Class I	1985-09-05
K852054	Contact Lens Loupe, Inspetion Loupe	Ascon Medical Instruments, Ltd.	HLN	Class I	1985-09-05
K852036	Air Plus Air Fluidized Therapy Systems	Air Plus, Inc.	INX	Class II	1985-09-05
K851975	Enteral Feeding Bag, 1000 Ml, & Tubing Set	Venusa Ltd.	KNT	Class II	1985-09-05
K853531	Ion Selective Electrode Subsystem Paramax Analyzer	American Dade	CEM	Class II	1985-09-04
K853464	Glucose Sr Liquid Stable Reagent Set	Medical Analysis Systems, Inc.	CFR	Class II	1985-09-04
K853372	Gemstar Ipa Theophylline Test Kit	Electro-Nucleonics Laboratories, Inc.	KLS	Class II	1985-09-04
K853268	Freeman Uni-Compartmental Knee	Protek, Inc.	HSX	Class II	1985-09-04
K853247	Acu-Slide-Test	Cal-Tech Diagnostics, Inc.	JHJ	Class II	1985-09-04
K853061	Mst Model #Arlg-5	Marlo Surgical Technology			1985-09-04
K853006	Human Chorionic Gonad Test Sys for Early Pregnancy	Modern Diagnostics, Inc.	JHI	Class II	1985-09-04
K852949	Welch Allyn #48100 Task Lite W/accessories as List	Welch Allyn Inc	KZF	Class I	1985-09-04
K852845	Prostatic Acid Phosphatase Radioimmunoassay	Siemens Healthcare Diagnostics Inc.	JFH	Class II	1985-09-04
K852386	Soft Mate Automatic Contact Lens Cleaning Unit	Barnes-Hind, Inc.	LPN	Class II	1985-09-04
K852055	Ascon Ophthalmic Sponge	Ascon Medical Instruments, Ltd.	HOZ	Class II	1985-09-04
K853379	Plate Incubator	Scientific Sales Intl., Inc.	JTQ	Class I	1985-09-03
K853363	H-H Cruciform-Slit Valve	Holter-Hausner Intl.	JXG	Class II	1985-09-03
K853362	H-H Slotted Ventricular Catheter/slotted Catheter	Holter-Hausner Intl.	JXG	Class II	1985-09-03
K853360	N20 Test	Erich Jaeger, Inc.	CBR	Class II	1985-09-03
K853356	Sera-210 Electrolyte Analyzer	Horiba Instruments Incorporated	CEM	Class II	1985-09-03
K853333	Dimension Total Hip Prosthesis	Kirschner Medical Corp.	KDI	Class II	1985-09-03
K853105	Immuno-Im	Immunostics, Inc.	KTN	Class II	1985-09-03
K853085	Pax Meter	Peace Medical, Inc.	JAX	Class II	1985-09-03
K853083	Reservior-Masterair Portable-Freedomair	Home Medical Supply, Inc.	BYJ	Class II	1985-09-03
K853065	#6003 Non Conductive Anesthesia Cir W/ Breath Bag	Sigma Medical, Inc.	CAI	Class I	1985-09-03
K852611	Test Urobilinogen in Urine & Leukocytes in Urine	Miles Laboratories, Inc.	CDM	Class I	1985-09-03
K852425	Cell Saver Suction System	Haemonetics Corporation	CAC	Class II	1985-09-03
K852372	Cell-Dyn Brand Hematology Reagents	Abbott Diagnostics	JPK	Class II	1985-09-03
K852355	Single Use Arthroscopy Electrode	Aspen Laboratories, Inc.	GEI	Class II	1985-09-03
K852349	Rhynostat H-12 & V-22	Remesta Medical Corp.	KPR	Class II	1985-09-03
K852239	Posicam Tm(model 3.2,4.3,6.5)	Position Corp.	KPS	Class II	1985-09-03
K852228	Esophageal Stethoscope with Electrical Conductors	Sensortek, Inc.	BZT	Class II	1985-09-03
K851879	Heated Respiratory Humidifier	Fisher & Paykel Allied Products, Ltd.	BTT	Class II	1985-09-03
K851288	Oxygen Delivery Measuring Device	Bar-Dix, Inc.	CAX	Class I	1985-09-03
K851095	Intraoral Dental X-Ray System 70-X	Trophy Radiologie	EHD	Class II	1985-09-03
K850646	Eclipse Self Adhering Electrode	Todd Medical, Inc.	GXY	Class II	1985-09-03
K853242	i.v. Start Kit, i.v. Restart Kit, Pedi-Kit,geri-Ki	U.S. Mfg. & Management, Inc.			1985-08-30
K853145	Kendall Curity Burn Pad	The Kendal Co.	FPY	Class I	1985-08-30
K852695	For Use in Ear; Nose & Throat Microsurgery	Minnesota Laser Corp.	EWG	Class II	1985-08-30
K852614	Atraum Wound Dressing	Axiom Medical, Inc.	FRO	Unclassified	1985-08-30
K852439	Feta Scan 1000 Obstetrical Imager	International Biomedics, Inc.	HEM	Class II	1985-08-30
K852171	Cat. No. S-5300-E Birthing Bed	Shampaine/Wilson	KNC	Class II	1985-08-30