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 2026-10-26, 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 2703 of 3530

510(k) clearances, page 2703 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K883378	Vista Mr 2055 Hp System	Philips North America LLC	LNH	Class II	1988-09-22
K883316	Quidel Pregnancy Test Control	Ortho-Clinical Diagnostics, Inc.	JJX	Class I	1988-09-22
K883308	Parker Bathing System	Mid-Canada Medical	ILJ	Class II	1988-09-22
K883240	Avl Model 986 Electrolyte Analyzer	Avl Scientific Corp.	CEM	Class II	1988-09-22
K883179	Hip Fracture Stem System	Howmedica Corp.	KWL	Class II	1988-09-22
K883103	Epicardia Pc/fc	Medicomp, Inc.	DSI	Class II	1988-09-22
K883002	Qm300 Prealbumin Antibody Pack	Kallestad Diag, A Div. of Erbamont, Inc.	JZJ	Class I	1988-09-22
K883001	Qm300 Calibrator D Pack	Kallestad Diag, A Div. of Erbamont, Inc.	CZJ	Class II	1988-09-22
K882922	Techmedica Mp System	Techmedica, Inc.	KTT	Class II	1988-09-22
K882907	Amerlite Tsh Assay, Lan.0001/2001 240 & 144 Kit	Amersham Corp.	JLW	Class II	1988-09-22
K882740	Access R-Clone(tm) Ana/rf Screening Assay	Lipogen, Inc.	LKJ	Class II	1988-09-22
K882678	Ite Hearing Aid, Siemens Model 007, with Telos	Siemens Hearing Instruments, Inc.	ESD	Class I	1988-09-22
K882631	Empi Model 727,Nms	Empi	GZJ	Class II	1988-09-22
K882525	Spinal Microknife	Karlin Technology, Inc.	HTS	Class I	1988-09-22
K882231	Sl Series, Sl 15, 18, 20 & 25 (Modification)	Philips North America LLC	IYE	Class II	1988-09-22
K882094	Gards Deodorant Sanitary Napkin	Hospital Specialty Co.	HHL	Class II	1988-09-22
K881341	Nova Lite(tm) Sa	Inova Diagnostics, Inc.	LLL	Class II	1988-09-22
K875072	Modified Amana Electrotherapeutic System	Amana Medical Group	GZJ	Class II	1988-09-22
K882867	Corpak Percutaneous Endoscopic Gastrostomy Tube	Corpak Co.	KNT	Class II	1988-09-21
K882018	Medacord Pvl, Personal Vascular Laboratory	Medasonics, Inc.	JAF	Class II	1988-09-21
K882009	King Kondom (Condom)	King Kondom Products, Inc.	HIS	Class II	1988-09-21
K883121	Quik-Pace II Electrodes	Physio Control, Inc.	DRO	Class II	1988-09-20
K883031	Q-Cath Rm	Quinton, Inc.	DXJ	Class II	1988-09-20
K882761	Transervical Endoscope (Hysteroscope)	Intramed Laboratories, Inc.	HIH	Class II	1988-09-20
K882683	Jobst Extremity Pump(r) System 7500	Jobst Institute, Inc.	JOW	Class II	1988-09-20
K882654	Physiotron(tm) Microsurgical Motor & Cooling Sys.	Surgical Innovators of America, Inc.	GEY	Class I	1988-09-20
K882594	The Omni-Flow Therapist Infusion Management System	Omni-Flow, Inc.	FRN	Class II	1988-09-20
K882592	Heart Hugger Sternum Support Harness	General Cardiac Technology, Inc.	KMO	Class I	1988-09-20
K881488	Holter Scanner	Cardiodata Corp.	DSI	Class II	1988-09-20
K883702	Excelview Illuminator	Excel Medical Products, Inc.	IXC	Class I	1988-09-19
K883503	Coulter Viscometer II	Coulter Electronics, Inc.	JJL	Class I	1988-09-19
K883463	Hospital Bed Clothing Cradle	Commercial Products & Engineering Co.	FNL	Class II	1988-09-19
K883395	Alkphor(tm) System, Human Serum Alka Phos Isoenzy	Quantimetrix Medical Industries	JJT	Class I	1988-09-19
K883210	Emit (R) Hva Negative Urine	Syva Co.	DIF	Class I	1988-09-19
K883181	Synchron Cx4/cx5 Clinical Chemistry Analyzer Reage	Beckman Instruments, Inc.	CKA	Class I	1988-09-19
K882891	A.c.i. Trach Tie	Auxiliary Care, Inc.	CBH	Class I	1988-09-19
K882729	Mevatron, M 2 Class	Siemens Medical Laboratories, Inc.	IYE	Class II	1988-09-19
K882663	Barbiturate Enzyme Immunoassay Kit	General Diagnostics	DIS	Class II	1988-09-19
K882326	Varian Clinac 1800S	Varian Assoc., Inc.	IYE	Class II	1988-09-19
K882133	Mammo M	Ziehm International, Inc.	IZH	Class II	1988-09-19
K881993	Pxi (Personal X-Ray Imager) 512	Oklahoma Digital Technologies, Inc.	LLZ	Class II	1988-09-19
K880426	Electrostimulator Model 808	Cornell Enterprises Co., Inc.	GZJ	Class II	1988-09-19
K880365	Model #1556 Heavy-Duty Joystick	Invacare GmbH	ITI	Class II	1988-09-19
K880364	Model #1555 Remote Joystick	Invacare GmbH	ITI	Class II	1988-09-19
K880363	Model #1554 Pneumatic Switch	Invacare GmbH	ITI	Class II	1988-09-19
K880362	Model #1553 Recliner Interface	Invacare GmbH	ITI	Class II	1988-09-19
K880361	Model #1552 Attendant Control Option	Invacare GmbH	ITI	Class II	1988-09-19
K880360	Model #1551 Switch Control Interface Unit	Invacare GmbH	ITI	Class II	1988-09-19
K875179	Modified Laserflo Blood Perfusion Monitor, Bpm403a	Tsi, Inc.	DPW	Class II	1988-09-19
K883682	Chang Medium (Additional Indications)	Hana Biologics, Inc.	KIT	Class I	1988-09-16