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 2922 of 3529

510(k) clearances, page 2922 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K860342	Microsample Coagulation Analyser, Model 110Wp	Bio/Data Corp.	JPA	Class II	1986-03-04
K860336	Hemodialysis Concentrates and Related Products	Breem Laboratories	FKQ	Class II	1986-03-04
K860297	Hemodialysis Concentrate Formulations/additives	Renal Hygienics	FKQ	Class II	1986-03-04
K860296	Hemodialysis Concentrate Formulations/additives	Physicians Surgeons Purchasing Group	FKQ	Class II	1986-03-04
K860247	Insta Kit for Group a Strep Id	Mead Johnson & Co.	GTZ	Class I	1986-03-04
K860153	Oxoid Antimicrobial Susceptibility Discs	Oxoid U.S.A., Inc.	JTN	Class II	1986-03-04
K860105	Spiral-Flex	Sheridan Catheter Corp.	BTR	Class II	1986-03-04
K855216	3M Arthroscopic Surgical System	3M Company	HWE	Class I	1986-03-04
K855167	Dyna System	Parker Laboratories, Inc.	EGG	Class I	1986-03-04
K855130	Tracheostomy Care Kit	Dynarex Corp.	BTO	Class II	1986-03-04
K854835	Dahlberg Model Gf Microprocessor Audiometer	Miracle-Ear/Dahlberg, Inc.	EWO	Class II	1986-03-04
K854834	Dahlberg Model Kc in-the-Ear Hearing Aid	Miracle-Ear/Dahlberg, Inc.	ESD	Class I	1986-03-04
K854803	Chameleon Bonding Kit	Pentron Corp.	EBF	Class II	1986-03-04
K854795	Hazelton Temporary Crown and Bridge Remover	Fran Hazelton Co.	EIS	Class I	1986-03-04
K854732	Api 50 Chb (Culture Media)	Dms Products, Inc.	JST	Class I	1986-03-04
K854625	Urotec Closed Irrigatiion Syringe	Urotec Systems Corp.	KOD	Class II	1986-03-04
K854530	Premium Flexi-Tough	The Hygenic Company, LLC	EGD	Class I	1986-03-04
K854527	Sticky Wax	The Hygenic Company, LLC	EGD	Class I	1986-03-04
K854430	Rigident Cream	Armkel, LLC	KOT	Class I	1986-03-04
K854278	Neg Combo Breakpoint Panel Pos Combo	American Micro Scan	JWX	Class I	1986-03-04
K853009	Cobas Bact Id Test Sys, Indole Spot Test Reagent	Roche Diagnostic Systems, Inc.	JSS	Class I	1986-03-04
K860672	Adjustable Oxygenator Holder Model No. Bcm-Hl	American Bentley	KRI	Class I	1986-03-03
K860623	Cellgro Hepes Buffer Solution	Mediatech, Inc.	KIT	Class I	1986-03-03
K860617	Polypet	Instrumed, Inc.	JTC	Class I	1986-03-03
K860536	Cefotetan 30 Mcg Sensi Disc	BD Becton Dickinson Vacutainer Systems Preanalytic	JTN	Class II	1986-03-03
K860527	Cefotetan 30 Mcg Sensitivity Discs	Difco Laboratories, Inc.	JTN	Class II	1986-03-03
K860522	Spirometer, Model Ts-1000, Part No. Slz7504	Teledyne Avionics Div. of Teledyne	BZG	Class II	1986-03-03
K860475	Hemoglobin Reagent Set	Sterling Diagnostics, Inc.	KHG	Class II	1986-03-03
K860208	Quadra-Titer I.d.	Microtech Medical Systems, Inc.	JSS	Class I	1986-03-03
K855220	V-Trend Kit Staph Latex Test	Texas Immunology, Inc.	JWX	Class I	1986-03-03
K855032	Imz Intramobile Cylinder Implant	Interpore Intl.	DZE	Class II	1986-03-03
K854787	Acuson L538 Transducer	Acuson Computed Sonography	ITX	Class II	1986-03-03
K854762	Hepanorm Calibration Plasma Set	American Bioproducts Co.	KFF	Class II	1986-03-03
K854619	Detectacult	Immunostics, Inc.	KHE	Class II	1986-03-03
K854464	IV Securement Devices	Avery Intl.	FRO	Unclassified	1986-03-03
K854463	Adhesive Tape, Wound Care, Wound Dressing	Avery Intl.	FRO	Unclassified	1986-03-03
K854359	Lm2000a Surgical Suction Monitor	Engineering, Inc.	KDQ	Class II	1986-03-03
K854241	Aot External Compress Device	Advanced Ortho-Technology, Inc.	HWN	Class I	1986-03-03
K853140	Mdi Quik Test Narcotics Drug Screen	Medical Diagnostics, Ca.	DNK	Class II	1986-03-03
K860530	Amylase Reagent Set (Modified Caraway)	Sterling Diagnostics, Inc.	CJA	Class II	1986-02-28
K860349	Lactate Dehydrogenase (Ldh) Reagent Set	Sterling Diagnostics, Inc.	CFH	Class II	1986-02-28
K860304	Dupont Phenobarbital Assay	E.I. Dupont de Nemours & Co., Inc.	LFN	Class II	1986-02-28
K860303	Dupont Phenobarbital Calibrator	E.I. Dupont de Nemours & Co., Inc.	LFN	Class II	1986-02-28
K860228	Sucrosep Human Growth Hormone (Hgh) Irma	Boots-Celltech Diagnostics, Inc.	CFL	Class I	1986-02-28
K860147	Carbon Dioxide Absorbents	Dentsply Intl.	CBL	Class I	1986-02-28
K860126	Stimuplex, Nerve Stimulator	Burron Medical Products, Inc.	BXN	Class II	1986-02-28
K855173	Delfia Tm Hlh Kit	Lkb Instruments, Inc.	CEP	Class I	1986-02-28
K855065	Prevent 0.2 Micron IV Filter W/vent & Extension Se	Cobe Laboratories, Inc.	FPB	Class II	1986-02-28
K855022	Computerized Anesthesia Recording & Info Network	Computerized Anesthesia Systems, Inc.	BSZ	Class II	1986-02-28
K855010	Quantimetric Plus Igm Reagent Kit	Kallestad Laboratories, Inc.	DFT	Class II	1986-02-28