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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3463 of 3526

510(k) clearances, page 3463 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K772257	Alkaline Phosphatase Test Set	Stanbio Laboratory	CIO	Class II	1977-12-22
K772254	Immunoglobulin M Nephel. Assay	Kallestad Laboratories, Inc.	DFT	Class II	1977-12-22
K772253	Transferrin Nephelometric Assay	Kallestad Laboratories, Inc.	DDG	Class II	1977-12-22
K772252	Immunoglobulin G Nephel. Assay	Kallestad Laboratories, Inc.	DEW	Class II	1977-12-22
K772251	Immunoglobulin a Nephel. Assay	Kallestad Laboratories, Inc.	CZP	Class II	1977-12-22
K772250	Alpha-1-Antitrypsin Nephel. Assay	Kallestad Laboratories, Inc.	DEI	Class II	1977-12-22
K772249	Complement C3 Nephelometric Assay	Kallestad Laboratories, Inc.	CEW	Class II	1977-12-22
K772248	Albumin Nephelometric Assay	Kallestad Laboratories, Inc.			1977-12-22
K772247	Complement C4 Nephelometric Assay	Kallestad Laboratories, Inc.	DBI	Class II	1977-12-22
K772246	Alpha-2-Macroglobulin Nephel. Assay	Kallestad Laboratories, Inc.	DEB	Class II	1977-12-22
K772245	Haptoglobin Nephelometric Assay	Kallestad Laboratories, Inc.	DAD	Class II	1977-12-22
K772243	Toxo Test	Gull Laboratories, Inc.	GLZ	Class II	1977-12-22
K772222	Nebulizer Set-2C7105	Travenol Laboratories, S.A.	CAF	Class II	1977-12-22
K772215	Unconjugated Estriol Ria Kit	Amersham Corp.	CGI	Class I	1977-12-22
K772211	Temp. Acrylic	Lactong Corp.	EBG	Class II	1977-12-22
K772196	Receptal Ats Trauma Kga1900l	Sorensen Research	CAC	Class II	1977-12-22
K772188	Fsh Ria Kit (125I)	Siemens Healthcare Diagnostics Inc.	FSH	Class I	1977-12-22
K772184	X-Ray System for Dental Application	General Electric Co.	EAP	Class II	1977-12-22
K772177	Tri-Tab-Ria	Nuclear Medical Laboratories, Inc.	CDP	Class II	1977-12-22
K772170	Emit Centrifichem Thyroxine Assay	Syva Co.	CDX	Class II	1977-12-22
K771894	Ldh Isoenzyme Control	Bio-Reagents & Diagnostics, Inc.	CEX	Class II	1977-12-22
K771854	Spinsep-T3	Nuclear Diagnostics, Inc.	KHQ	Class II	1977-12-22
K771429	Disp. Teflon Connhctor	Quinton, Inc.	FJQ	Class I	1977-12-22
K772299	Transparent Manifold	Uni-Research	DTL	Class II	1977-12-21
K772291	Diag. Console, Independent	Pfizer Inc	JAK	Class II	1977-12-21
K772289	Scanner, CT, 0400	Pfizer Medical Systems, Inc.	JAK	Class II	1977-12-21
K772301	Laparoscopy Drape, Boundary	Procter & Gamble Mfg. Co.	FZT	Class I	1977-12-20
K772292	T-Tube Whelan-Moss	Davol, Inc.	GCA	Class II	1977-12-20
K772286	Forceps, Suture, Auto	Hartmann Group, Inc.	GDO	Class I	1977-12-20
K772271	Walker Folding Adjustable	Med Fusion Systems, Inc.	ITQ	Class I	1977-12-20
K772270	Setup Walker Over Toilet Construc.	Med Fusion Systems, Inc.	ITQ	Class I	1977-12-20
K772269	Setup Walker Adjustable	Med Fusion Systems, Inc.	ITQ	Class I	1977-12-20
K772268	Demi-Walker (Regular)	Med Fusion Systems, Inc.	ITQ	Class I	1977-12-20
K772267	Quadraplegic Walking Aid	Med Fusion Systems, Inc.	IPS	Class I	1977-12-20
K772242	Laparoscopy Console Model VIII	Kli	HET	Class II	1977-12-20
K772233	Thermometer Recal Adapter	Info-Chem	FQZ	Class I	1977-12-20
K772227	Cath Kit, Superpubic	American Hospital Supply	KXF	Class I	1977-12-20
K772209	Culture Collec. Trans. Sys., Double Dry	Precision Dynamics Corporation	JTW	Class I	1977-12-20
K772207	Culture Collec. Trans. Sys., Single Wet	Precision Dynamics Corporation	JTW	Class I	1977-12-20
K772202	Pulse Generator, a-V Seq.	Medtronic, Inc.	DXY	Class III	1977-12-20
K772201	Hearing Aid, Body Type, Model H	Maico Hearing Instruments, Inc.	ESD	Class I	1977-12-20
K772183	Thyroid Binding Globulin	Corning Medical & Scientific	CEE	Class II	1977-12-20
K772181	Prophylactic	Om Industries, Inc.	HIS	Class II	1977-12-20
K772179	Emit Antiepileptic Drug Assays	Syva Co.	DIP	Class II	1977-12-20
K772176	Cystic Fibrosis Testing Instrument	Laboratory Equipment Design Co.	JJN	Class I	1977-12-20
K772138	Endotracheal Tube	MEDLINE INDUSTRIES, LP - Northfield	BTO	Class II	1977-12-20
K772136	Peritoneal Cycler & Manifold Set	Physio Control, Inc.	KDJ	Class II	1977-12-20
K772120	Total Hip, Charnely Type	Depuy, Inc.	JDG	Class II	1977-12-20
K772098	Digoxin Reag. Kit for Use W/aria-II Sys	BD Becton Dickinson Vacutainer Systems Preanalytic	DON	Class II	1977-12-20
K772066	Pullen Plastic-Pore Plugs	Richard'S Medical Equip., Inc.	ETD	Class II	1977-12-20