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 3353 of 3526

510(k) clearances, page 3353 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K801162	Barrier Plus Surgeon Gowns	American Hospital Supply	FYC	Class II	1980-05-23
K801158	Ndm Diatemp Electrosurgical Dis. Pad	Ndm Corp.	GEI	Class II	1980-05-23
K801156	Usci Intraluminal Graft W/dacron Tie	C.R. Bard Inc	DSY	Class II	1980-05-23
K801131	Il88640 & 88641 Cassette-Tape Program	Instrumentation Laboratory Co.	JQP	Class I	1980-05-23
K801111	Pediatric Anesthesia Circuit	Vital Signs, Inc.	CAI	Class I	1980-05-23
K801104	Roommate-Oxygen Concentrator	Cryogenic Assoc.	CAW	Class II	1980-05-23
K801087	Neonatal Breathing Circuit System	Isothermal Systems, Inc.	BZO	Class I	1980-05-23
K801084	Cybrex Gentamicin	Abbott Medical	LCQ	Class II	1980-05-23
K801071	Lancer Glucose Rate Reagent Kit	Sherwood Medical Industries	CGA	Class II	1980-05-23
K801052	Data-Zyme Glucose Hexokinase UV	Data Medical Associates, Inc.	CFR	Class II	1980-05-23
K801051	Data-Zyme Glucose Hexokinase Colozimetri	Data Medical Associates, Inc.	CFR	Class II	1980-05-23
K801041	3M r.f. Current Suppressor	3M Company	DSA	Class II	1980-05-23
K801005	Mlt Tube Microlaryngeal Tracheal Tube)	National Catheter Co. Div. Mallinckrodt	BTR	Class II	1980-05-23
K800985	Thioglycollate Med. W/o Indicator	Quality Assurance Laboratory, Inc.	JSG	Class I	1980-05-23
K800984	Eosin Methylene Blue Agar, Levine	Quality Assurance Laboratory, Inc.	JSH	Class I	1980-05-23
K800983	Macconkey Agar	Quality Assurance Laboratory, Inc.	JSI	Class I	1980-05-23
K800982	Salmonella Shigella Agar	Quality Assurance Laboratory, Inc.	JSH	Class I	1980-05-23
K800980	Hextoen Enteric Agar	Quality Assurance Laboratory, Inc.	JSI	Class I	1980-05-23
K800979	Mueller Hintin Agar W/5% Sheep Blood	Quality Assurance Laboratory, Inc.	JTZ	Class II	1980-05-23
K800977	Thayer-Martin Agar	Quality Assurance Laboratory, Inc.	JTY	Class II	1980-05-23
K800937	R2 Plate Type Cable-Adaptor #S 175,176	R2 Corp.	LDD	Class II	1980-05-23
K800936	R2 Paddle Type Cable-Adaptor #S 170,171	R2 Corp.	LDD	Class II	1980-05-23
K800935	R2 Apex-Post.,ant.&post. Elect.(12 Mods)	R2 Corp.	DRX	Class II	1980-05-23
K800932	ECG-RF-Choke Cable-Adapter #'S 121,120	R2 Corp.	DSA	Class II	1980-05-23
K800931	R2(tm) ECG Cable-Adaptor #'S 120-121-122	R2 Corp.	DSA	Class II	1980-05-23
K800930	R2(tm) ECG Electrode Set-#'S305-306 Etc.	R2 Corp.	DRX	Class II	1980-05-23
K800899	Lab-Tek Anacult Anaerobic Culture Chambe	Miles Laboratories, Inc.	KZJ	Class I	1980-05-23
K800865	Windsor	Trident Dental, Inc.	BZR	Class II	1980-05-23
K800742	Liberator/stroller II System	Cryogenic Assoc.	BYJ	Class II	1980-05-23
K800576	Cyclopac Cp100 TENS Bandage	Cyclotechnical Medical Indust., Inc.	GZJ	Class II	1980-05-23
K801153	Valleylab Return Electrode Monitor	Medtronic, Inc.	GEI	Class II	1980-05-20
K801151	Disposable Skin Retractor	Cimarron Instruments, Inc.	GZT	Class II	1980-05-20
K801132	Boundary Extremity Drape	Procter & Gamble Mfg. Co.	KKX	Class II	1980-05-20
K801120	Dunn Anterior Distraction System	Zimmer GmbH	KWP	Class II	1980-05-20
K801110	Pressure Monitor, Model 1131B	American Optical Corp.	DSK	Class II	1980-05-20
K801097	Sarns 7000 Monitor Module	3M Health Care, Sarns	DTQ	Class II	1980-05-20
K801093	Prisma-Bond	Dentsply Intl.	KLE	Class II	1980-05-20
K801092	Prisma-Fill	Dentsply Intl.	EBF	Class II	1980-05-20
K801080	Edwards Rod Sleeves	Zimmer GmbH	KWP	Class II	1980-05-20
K801079	Kwix-Bite X-Ray Film Holder	Henry Schein, Inc.	EGZ	Class I	1980-05-20
K801075	Straith Chisel Forceps	Surgical Technology Laboratories Inc.	GEN	Class I	1980-05-20
K801073	Straith Chin Implants	Surgical Technology Laboratories Inc.	FWP	Class II	1980-05-20
K801069	Sterile Isolation Gown	Medspec Corp.	FYC	Class II	1980-05-20
K801068	Sterile Abdominal Pad	Medspec Corp.	KKX	Class II	1980-05-20
K801047	Ply Lesive	May-Pell Chemical Development Co.	LBH	Class II	1980-05-20
K801033	Sterile Drape 17X18 W/3 Fenestration	Veratex Corp.	KKX	Class II	1980-05-20
K801032	Sterile Drape 17X18 Code D-6A	Veratex Corp.	KKX	Class II	1980-05-20
K801028	Rica or Smic Surgical Instruments	Robert I. Chien & Assoc., Inc.	HXD	Class I	1980-05-20
K801019	125I-Ige Radioimmunoassay Kit	Bio-Ria	DGC	Class II	1980-05-20
K801010	Kirschner Wire	American Safety Equipment Corp.	HSB	Class II	1980-05-20