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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2606 of 3530

510(k) clearances, page 2606 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K894528	Fpr Phenytoin Calibrator Kit	Colony Laboratories, Inc.	DLG	Class I	1989-09-25
K894527	Fpr Phenytoin Kit	Colony Laboratories, Inc.	DLP	Class II	1989-09-25
K894522	Fpr Digoxin Calibrator Kit	Colony Laboratories, Inc.	DLJ	Class II	1989-09-25
K894521	Fpr Digoxin Kit	Colony Laboratories, Inc.	KXT	Class II	1989-09-25
K894407	Abbott Spectrum(r) Calcium Reagent	Abbott Medical	CIC	Class II	1989-09-25
K894200	Free T3 Radioimmunoassay Kit	Advanced Magnetics, Inc.	CDP	Class II	1989-09-25
K894097	Nti-1000	Neurotek, Inc.	QJQ	Class II	1989-09-25
K893569	Quick Change Montgomery Strap	Med-Dex Intl.	KGX	Class I	1989-09-25
K892895	Model 8800 Bipolar Coagulation Therapeutic System	Everest Medical Corp.	KNS	Class II	1989-09-25
K891129	Series 3 General Suction System	Ultravac, Inc.	BTA	Class II	1989-09-25
K885220	Percutaneous Endoscopic Gastrostomy Kit	Ethox Corp.	KNT	Class II	1989-09-25
K895586	Vvr/q Calorimeter	Vita-Stat	BZL	Class II	1989-09-22
K895537	Modified Memory Retractor Arm	Medical Equipment Development Co., Inc.	GZT	Class II	1989-09-22
K895188	Shimadzu X-Ray Tube Stand Fh-31	Shimadzu Medical Systems	IYB	Class I	1989-09-22
K894875	20Ga X 7-1/2 Threading Bullet Point Needle	R. J. Doyle, Inc.	GAA	Class I	1989-09-22
K894874	14 Inch Bullet Point Needle	R. J. Doyle, Inc.	GAA	Class I	1989-09-22
K894873	16 Ga X 10 Bullet Point Needle	R. J. Doyle, Inc.	GAA	Class I	1989-09-22
K894872	16 Ga X 6 Bullet Point Needle	R. J. Doyle, Inc.	GAA	Class I	1989-09-22
K894637	National Medical Care Venous Line 03-9548	National Medical Care, Medical Products Div., Inc.	KOC	Class II	1989-09-22
K894432	Modified Ham's F-10 W/albumin	Irvine Scientific LLC	HDR	Class II	1989-09-22
K894413	X-Ray Tube Housing Assembly, Various Models	Inmark Corp.	ITY	Class I	1989-09-22
K894405	Htf with Albumin (Catalog No. 9994)	Irvine Scientific LLC	HDR	Class II	1989-09-22
K894316	Amadeus Ventilator	Hamilton Medical AG	CBK	Class II	1989-09-22
K894299	Repro-Med Emergency Airway Vacuum System	Repro-Med Systems, Inc.	BSY	Class I	1989-09-22
K894296	Premise Series Bed	Batesville American Mfg. Co.	FNL	Class II	1989-09-22
K893786	Servo Anesthesia Circle 985	Siemens Life Support Systems	CBK	Class II	1989-09-22
K893745	The Independent Care Unit	The Water Carriage Co., Inc.	FNL	Class II	1989-09-22
K892670	Physio-Dyne Easi (Easy Analog Sampling Interface)	Physio-Dyne Instrument Corp.	BZC	Class II	1989-09-22
K891928	Holtain Body Composition Analyser	Seritex, Inc.	DSB	Class II	1989-09-22
K891688	Coil and Coil Delivery System	Target Therapeutics	HCG	Class II	1989-09-22
K895377	Qm300 Ceruloplasmin Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DDB	Class II	1989-09-21
K895371	Flex Eyewear Frames	Flex Eyewear, Inc.	HQZ	Class I	1989-09-21
K895300	Multiple Mental Spectacle Frames	Optica Trade S.A.	HQZ	Class I	1989-09-21
K895294	Progene Ige Bead Eia	Progene Corp.	DGC	Class II	1989-09-21
K894835	Lasermed* Goggles and Spectacles	Glendale Protective Technologies, Inc.	HQF	Class II	1989-09-21
K894696	Latex Patient Examination Gloves	Sun Holy Manufactory, Ltd.	LYY	Class I	1989-09-21
K894659	Ana Antisera Control Kit	Lipogen, Inc.	DHN	Class II	1989-09-21
K894499	Armor, Latex Examination Gloves	Prestige Manufacturing Snd Bhd	LYY	Class I	1989-09-21
K894386	Latex Examination Gloves	Ningbo Yujiang Plastic & Rubber Co., Ltd.	LYY	Class I	1989-09-21
K894375	Patient Examination Gloves	Pan-Century Rubber Products Sdn. Bhd.	LYY	Class I	1989-09-21
K894196	Patient Examination Gloves	Lanka Products, Inc.	LYY	Class I	1989-09-21
K894178	Patient Exam Gloves (Mfg: Gloves Int'l Ltd.)	Lanka Products, Inc.	LYY	Class I	1989-09-21
K894103	Scimed Ultrox True Membrane Oxygen Syst, Ultrox II	Scimed Life Systems, Inc.	DTZ	Class II	1989-09-21
K894080	Latex Examination Gloves	Shanghai Intl. Corp.	LYY	Class I	1989-09-21
K894019	Resound Demo. Behind-the-Ear Hrng., Model Demo Bte	Resound Corp.	KHL	Class II	1989-09-21
K893996	Cusis Ultrasound Skin Imaging System	Stiefel Research Institute, Inc.	IYO	Class II	1989-09-21
K893882	Latex Examination Gloves	Sinochem (USA), Inc.	LYY	Class I	1989-09-21
K893271	Vinyl Exam Gloves	Consul Chemical Industry Corp.	LYZ	Class I	1989-09-21
K893171	Vista Streak Retinoscope (Ac-Powered)	Keeler Instruments, Inc.	HKL	Class II	1989-09-21
K893000	Globe Patient Examination Gloves	Lucky and Happy, Inc.	LYY	Class I	1989-09-21