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 2026-10-19, 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 3042 of 3529

510(k) clearances, page 3042 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K843239	Dacos Plus Lytes Option	Coulter Electronics, Inc.	CEM	Class II	1984-10-17
K843082	Analox Lm3 Micro-Stat Analyser	Analox Instruments, Ltd.	JJE	Class I	1984-10-17
K842797	Toxoplasma Gondii Igm Eia Test Kit	Labsystems, Inc.	LGD	Class II	1984-10-17
K842717	Cobas-Fibro	Roche Diagnostic Systems, Inc.	JPA	Class II	1984-10-17
K842394	Astra 2, Astra 3, 4 & 6	Cardiac Pacemakers, Inc.	DXY	Class III	1984-10-17
K841243	Enzygnost Rotavirus Ag	Behring Diagnostics, Inc.	LIQ	Class I	1984-10-17
K843849	Pneumoscreen	Erich Jaeger, Inc.	BZC	Class II	1984-10-16
K843523	Empty Solution Transfer Container 1000	Polymer Technology Corp.	KPE	Class II	1984-10-16
K843309	Uniflex Danninger	Buckman Co., Inc.	BXB	Class I	1984-10-16
K842984	Extension Set W/injection Site	Med Fusion Systems, Inc.	FPA	Class II	1984-10-16
K831822	Tetraflex Integrally Supported PTFE	Shiley, Inc.	DSY	Class II	1984-10-16
K843401	Ria Panty Shields	Paul Hartmann AG	HHD	Class I	1984-10-15
K843318	Laurier Sanitary Napkin	Kao Corp.	HHD	Class I	1984-10-15
K843217	Hollow Basket Dental Implants	Artech Corp.	DZE	Class II	1984-10-15
K842837	Safe & Soft Maxi Shileds	Ipco Corp.	HHD	Class I	1984-10-15
K842836	Safe & Soft Mini Pads & Maxi Pads	Ipco Corp.	HHD	Class I	1984-10-15
K842689	Glyco-Tek Affinity Column	Helena Laboratories, Corp.	LCP	Class II	1984-10-15
K842351	Sterile Design-Custom Sterile IV Kit	Sterile Design, Inc.	FPA	Class II	1984-10-15
K842001	Liver Biopsy Tray	Jayco Pharmaceuticals			1984-10-15
K841958	Cardio Metrics Cardiotomy Reservoir	Sterile Design, Inc.	JOD	Class II	1984-10-15
K822440	Percutaneous Cricothyroidotomy	Frederic J. Toye, M.D.	BTO	Class II	1984-10-15
K832753	Percutaneous Balloon	Smec, Inc.	DSP	Class II	1984-10-13
K843847	O2 Test	Erich Jaeger, Inc.	CCL	Class II	1984-10-12
K843845	Co Test	Erich Jaeger, Inc.	CCJ	Class II	1984-10-12
K843844	CO2 Test	Erich Jaeger, Inc.	CCK	Class II	1984-10-12
K843840	N2 Test	Erich Jaeger, Inc.			1984-10-12
K843793	A-T TENS Belt	A-T Surgical Mfg. Co., Inc.	GZJ	Class II	1984-10-12
K843585	Bemco Portable Oxygen Inhalator	Bemco, Inc.	CAN	Class I	1984-10-12
K842779	Act, Suction Tip	Edward Manougian, M.D.	BSY	Class I	1984-10-12
K842303	Microspan -Ph Monitor	Biochem International, Inc.	CBF	Class II	1984-10-12
K842295	Intrauterine Device Remover	Premier Dental Products Co	HHF	Class I	1984-10-12
K843831	Albumin Reagent Set	Livonia Diagnostics, Inc.	CIX	Class II	1984-10-11
K843750	Apparatus, Suction, Ward Use, Portab-	H.C.H. Products, Inc.	BTA	Class II	1984-10-11
K843685	C-Terminal/mid-Molecule Parathyroid -	Nichols Institute Diagnostics	CEW	Class II	1984-10-11
K843536	Triglyceride Assay Kit Gpo-Cp	Diagnostic Chemicals, Ltd. (USA)	CDT	Class I	1984-10-11
K843529	Astra Systems Amylase Reagent Kit	Beckman Instruments, Inc.	CJA	Class II	1984-10-11
K843480	Pharma-Plast Urinary Drainage Bag 2000	Zimmar Consulting, Ltd.	KNX	Class II	1984-10-11
K843479	Pharma-Plast Leg Bag	Zimmar Consulting, Ltd.	KNX	Class II	1984-10-11
K843463	Provider Bag Spike W/12 Microbore Exten	Pancretec, Inc.	FPA	Class II	1984-10-11
K843395	Encore Tsh Reagent	Hybritech, Inc.	JLW	Class II	1984-10-11
K843392	Gauderer Gastrostomy Button	American V. Mueller	KNT	Class II	1984-10-11
K843381	Uri Tx-100 Multichannel Thermocouple	Uri Therm-X, Inc.	FLL	Class II	1984-10-11
K843305	Davol Gauderer-Ponsky Percutan-Endoscop	C.R. Bard Inc	KNT	Class II	1984-10-11
K843254	Dk*300 Volumetric Infusion Controller	Deka Research & Development Corp.	LDR	Class II	1984-10-11
K843209	Phenytoin Aca Analytical Test Pack	E.I. Dupont de Nemours & Co., Inc.	DIP	Class II	1984-10-11
K843117	Green Cross Urinary Drainage Bag	Tech-Cons Ltd., Intl.	KNX	Class II	1984-10-11
K843081	Tugs-Transportable Univ. Gradient Suct	Creative Medical Laboratories, Inc.	JCX	Class II	1984-10-11
K843059	Atac 2000	Turpen Laboratory Systems, Inc.	JJE	Class I	1984-10-11
K842966	Renin Radioimmunoassay Test Kit	Serono Diagnostics, Inc.	CIB	Class II	1984-10-11
K842965	Gastrin Radioimmunoassay Test Kit	Serono Diagnostics, Inc.			1984-10-11