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 2936 of 3529

510(k) clearances, page 2936 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K854443	O'neil Urinary Catheter Introducer	Pennine Medical, Ltd.	KOD	Class II	1986-01-08
K854397	Hemostatic Sidearm	Target Therapeutics	DTL	Class II	1986-01-08
K854391	Hemodialysis Concentrate	Dana Laboratories	FKQ	Class II	1986-01-08
K854357	Gem-6, with Components	Diamond Electro-Tech, Inc.	DRY	Class II	1986-01-08
K854282	Preview Xt	Cambridge Medical Instruments, Inc.	DSI	Class II	1986-01-08
K854259	Sepacell R-500 & Sepacell R-500A	Advocacy International, Ltd.	CAK	Class II	1986-01-08
K854233	Cmi 3000	Cardio Management, Inc.	DRO	Class II	1986-01-08
K854133	Bio Medicus Bio Console 540	Bio Medicus, Inc.	DWA	Class II	1986-01-08
K854113	Cardioplegia Heat Exchanger Holder He-100Sh	American Bentley	KRI	Class I	1986-01-08
K853747	Navigator	Mainsfield Scientific, Inc.	DTB	Class III	1986-01-08
K853406	Gambro Lundia Pro 3 & 5 Dialyzer	Gambro, Inc.	FJG	Class II	1986-01-08
K853132	Emerson Tro/cath Trocar Catheters	J. H. Emerson Co.	DRC	Class II	1986-01-08
K851573	Abbott Pharamacokinetics Systems	Abbott Medical	NDC	Class II	1986-01-08
K843189	Cytomegalovirus Igg Eia Test Kit	Labsystems, Inc.	GQI	Class II	1986-01-08
K855110	Dri-Form Ureaplasma Differential Basal Agar Med.a8	Gibco Laboratories Life Technologies, Inc.	JSI	Class I	1986-01-07
K855109	Clearene, Clearing Agent	Surgipath Medical Industries, Inc.	KEM	Class I	1986-01-07
K854967	Critic - Sf, Assayed	Dimension Diagnostics	JJY	Class I	1986-01-07
K854838	Lee-Bead Beta Lh (Eia)	Leeco Diagnostics, Inc.	CEP	Class I	1986-01-07
K854716	Nsi Astra Tm Calcium Reagent Kit Nsi Item # 7909	Nobel Scientific Industries, Inc.	CIC	Class II	1986-01-07
K854546	Microsample Coagulation Analyser Model 110P	Bio/Data Corp.	JPA	Class II	1986-01-07
K854379	Micro-Elisa Tsh Test Kit-Visi-Check Tsh Test Kit	Bioclinical Systems, Inc.	JLW	Class II	1986-01-07
K854195	Programalith III Models 238 & 239	Pacesetter Systems	DXY	Class III	1986-01-07
K854041	Cd-100 Cardiac Monitor	Cardio Display Corp.	DRT	Class II	1986-01-07
K853951	Isotrak Amylase Test Amylase Isoenzyme	Behring Diagnostics, Inc.	CIJ	Class II	1986-01-07
K853038	De12 Rapid Trace at-Rest Diagnostic ECG Electrodes	ZOLL Medical Corporation	DRX	Class II	1986-01-07
K854699	Tubing Syring	Almore Intl., Inc.	ECB	Class I	1986-01-06
K854090	Diatimer-2 Blood Plasma Clot Timing Instrument	Diatech, Inc.	JPA	Class II	1986-01-06
K854089	Diatimer-1 Blood Plasma Clot Timing Instrument	Diatech, Inc.	JPA	Class II	1986-01-06
K853641	Godde T-Tube Blue Silicone Tympanostomy Tube	Xomed, Inc.	ETD	Class II	1986-01-06
K852947	Adr 3160 W/probes Plb-308M, Plb-508M, & Plb-310M	Advanced Technology Laboratories, Inc.	ITX	Class II	1986-01-06
K852387	Goode T-Tube White Silicone Tympanostomy Tube	Xomed, Inc.	ETD	Class II	1986-01-06
K854986	Bbl Port-a-Cul Aerobic Transport Sys, Modified Stu	BD Becton Dickinson Vacutainer Systems Preanalytic	JSM	Class I	1986-01-03
K854947	Rehabilitation Tables	I-Rep, Inc.	INQ	Class I	1986-01-03
K854861	Setma Hygia Bath Model St 7200	Setma, Inc.	ILJ	Class II	1986-01-03
K854760	Churchhill Lancet	Churchill Corp.	FMK	Class II	1986-01-03
K854635	Electra Chiropract/equip Table Electra I&stationar	Electra Equipment, Ltd.	INQ	Class I	1986-01-03
K854632	Endotracheal Tube Guide or Intubation Stylette	Respiratory Support Products, Inc.	BTR	Class II	1986-01-03
K854612	Acute Hemodialysis Tray, Cat.#09-9540-7	Med-West, Inc.	LFK	Class II	1986-01-03
K854573	Anesthesia Shutoff Valve Positive Closure	Artec Environmental Monitoring Division	CAI	Class I	1986-01-03
K854447	Immunoscan Rapid Direct Group a Strep Test	American Micro Scan	GTZ	Class I	1986-01-03
K854374	Oxygen Concentrator, Model Bx-5000	Healthdyne, Inc.	CAW	Class II	1986-01-03
K854212	Acoustascope Esophageal Stethoscope W/temp Sensor	Respiratory Support Products, Inc.	BZT	Class II	1986-01-03
K854081	Imagen Respiratory Syncytial Virus Test	Boots-Celltech Diagnostics, Inc.	GQG	Class I	1986-01-03
K854016	Asserachrom Protein C Kit	American Bioproducts Co.	JLA	Class I	1986-01-03
K854014	Assera Plate Ix:ag Kit	American Bioproducts Co.	GGP	Class II	1986-01-03
K853849	Medar Apm Force Transducer	Medar Corp., Inc.	BXN	Class II	1986-01-03
K853710	Theracushion	General Physiotherapy, Inc.	ISA	Class I	1986-01-03
K852632	Gas/pres Monit Endot Tub Conn/adop W/ & W/o Tub	Medicomp, Inc.	CAI	Class I	1986-01-03
K852527	Satalec Septosonic Sc 80/Sc 120	Spelna, Inc.	FLG	Class I	1986-01-03
K852034	Vitatron M	Elmed, Inc.			1986-01-03