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 2872 of 3529

510(k) clearances, page 2872 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K863548	Rotary Microtome	Surgipath Medical Industries, Inc.	IDO	Class I	1986-09-19
K863527	Cary-Blair Transport Medium	BD Becton Dickinson Vacutainer Systems Preanalytic	JSM	Class I	1986-09-19
K863526	Yep (Yeast Extract Phosphate) Agar	BD Becton Dickinson Vacutainer Systems Preanalytic	JSJ	Class I	1986-09-19
K863525	Dermatophyte Test Medium, Slants and Mycoflasks	BD Becton Dickinson Vacutainer Systems Preanalytic	JSI	Class I	1986-09-19
K863524	Regan-Lowe Charcoal Agar	BD Becton Dickinson Vacutainer Systems Preanalytic	JSJ	Class I	1986-09-19
K863523	Toc (Tween 80 - Oxgall-Caffeic Acid) Agar	BD Becton Dickinson Vacutainer Systems Preanalytic	JSH	Class I	1986-09-19
K863522	Modified Self-Cure Bonding Agent	Dentsply Intl.	KLE	Class II	1986-09-19
K863519	Cal (Cellobiose-Arginine-Lysine) Agar	BD Becton Dickinson Vacutainer Systems Preanalytic	JSI	Class I	1986-09-19
K863507	Physi. & Nurses Brand Instant Kold & Hot Kompress	Physician & Nurses Mfg. Corp.	IMD	Class I	1986-09-19
K863484	Siemens Sirona(r) Dental Chair	KaVo Dental Technologies, LLC	KLC	Class I	1986-09-19
K863375	Sea-Bond	Combe, Inc.	KXX	Class I	1986-09-19
K863358	Varian Rms-2000	Varian Assoc., Inc.	IYE	Class II	1986-09-19
K863322	Modified Mahurkar Subclavian & Femoral Catheters	Quinton, Inc.	DQY	Class II	1986-09-19
K863197	Vibroflex	Stoffregen & Co., Inc.	ISA	Class I	1986-09-19
K863178	Umi Steerable Torque Guide Wire	Universal Medical Instrument Corp.	DQX	Class II	1986-09-19
K863092	Dental Composite Restorative	Dentsply Intl.	EBF	Class II	1986-09-19
K862983	Additional Target Therapeutics Guide Wires	Target Therapeutics	DQX	Class II	1986-09-19
K862962	Apnet Respiration Monitor	Wireless Monitors, Inc.	BZQ	Class II	1986-09-19
K862862	Model 10-C W/fl-10A/u for Surgery and Dermatology	Directed Energy, Inc.	GEX	Class II	1986-09-19
K862829	Panagraf	Panadent International, Inc.	KLE	Class II	1986-09-19
K862406	Nozees Nostril Dilator	Nozees Co.	LWF	Class I	1986-09-19
K862151	Color Flow Mapping (Cfm) Option - Model 77020 Cf	Hewlett-Packard Co.	IYO	Class II	1986-09-19
K862054	Model 430-01 Biopore Implantable Pacing Lead	Intermedics, Inc.	DTB	Class III	1986-09-19
K862053	Model 432-01 Biopore Implantable Pacing Lead	Intermedics, Inc.	DTB	Class III	1986-09-19
K863546	Cpu Graph	GE Healthcare	CBK	Class II	1986-09-18
K863505	Uresil Closed Drainage Reservoir	Uresil, LLC	GCY	Class I	1986-09-18
K863432	Oxygen Cannula Ear Wrap (Style B)	Salter Labs	CAT	Class I	1986-09-18
K863431	Oxygen Cannula Ear Wrap (Style a)	Salter Labs	CAT	Class I	1986-09-18
K863397	Byron Silicone Chin Implants	Byron Medical	FWP	Class II	1986-09-18
K863035	Polyhesive R Electrodes/tens Muscle Stim Elec Ther	Medtronic, Inc.	GXY	Class II	1986-09-18
K862712	Emerson Model 3Hv Compact Ventilator	J. H. Emerson Co.	CBK	Class II	1986-09-18
K862671	Microalbuminuria Assay	Orion Corp.	DCF	Class II	1986-09-18
K863485	Modification of Cdt(tm) Clostridium Test	Marion Laboratories, Inc.	LLH	Class I	1986-09-17
K863443	Dual Forceplate	Neurocom International, Inc.	KHX	Class I	1986-09-17
K863433	Model 8900 Nd:yag Laser	Cooper Lasersonics, Inc.	GEX	Class II	1986-09-17
K863430	Byron Bivalve Nasal Splints	Byron Medical	FZE	Class II	1986-09-17
K863414	Microbipolator	Treace Medical, Inc.	GEI	Class II	1986-09-17
K863400	Byron Extended Malar and Byron Contoured Malar	Byron Medical	LZK	Class II	1986-09-17
K863399	Byron Dorsal Columella Implant	Byron Medical	FZE	Class II	1986-09-17
K863398	Byron Nasal Septal Button	Byron Medical	FZE	Class II	1986-09-17
K863355	Phadiotop (Tm) Ria/phadiotop (Tm) Eia	Pharmacia, Inc.	DHB	Class II	1986-09-17
K863352	Precimat (R) Iga, G, M	Boehringer Mannheim Corp.	CZP	Class II	1986-09-17
K863262	Total Bilirubin Procedure	Data Medical Associates, Inc.	CIG	Class II	1986-09-17
K863226	Albumin (Bcp)	Sigma Diagnostics, Inc.	CJW	Class II	1986-09-17
K863203	Cholinesterase (Btc) Reagent	Sigma Diagnostics, Inc.	DIH	Class I	1986-09-17
K863129	3M Corneal System (Corneal Preservation Medium)	3M Company	LYX	Unclassified	1986-09-17
K863116	Cardiofax ECG-6551 (Electrocardiogrph)	Nihon Kohden America Inc	DPS	Class II	1986-09-17
K862978	Resistant 6 Mic Panel	Pasco Laboratories, Inc.	JWY	Class II	1986-09-17
K862363	Insert Earphones	Cadwell Laboratories, Inc.	GWJ	Class II	1986-09-17
K862361	40-Hz Auditory Evoked Response Test	Cadwell Laboratories, Inc.	GWJ	Class II	1986-09-17