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 2691 of 3530

510(k) clearances, page 2691 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K883597	Myodac	Thought Technology Ltd.	HCC	Class II	1988-11-16
K883236	Cefar Dual	Cefar Medical Products, Inc.	GZJ	Class II	1988-11-16
K883038	P/n 9320 Low Flow Air/oxygen Microblender	Bird Products Corp.	BZR	Class II	1988-11-16
K881800	Bcs No. 1, Body Care System	M & A Vertrieb, Liske und Methling GM	IRT	Class II	1988-11-16
K875378	Single Photon Set 031 & Az-701-Nts-Sp Emission	Shimadzu Precision Instruments, Inc.	KPS	Class II	1988-11-16
K872111	Orthotone	Orthotone Corp.	HLL	Class II	1988-11-16
K884360	Seiko P-6 Progressive Spectacle Lenses	Seiko Corp.	HQG	Class I	1988-11-15
K883926	.2Mm, .4Mm, .5Mm Irrigation and Aspiration Hand.	Site Microsurgical Systems, Inc.	HQE	Class II	1988-11-15
K883738	Carbon Dioxide Laser System Model 20-Cx W/attach.	Directed Energy, Inc.	GEX	Class II	1988-11-15
K883604	Medrad Image Management System (Mims)	Medrad, Inc.	LLZ	Class II	1988-11-15
K883561	Bard(r) Ureteral Stent W/suture	C.R. Bard Inc	FAD	Class II	1988-11-15
K882464	Dtl Microtouch Eye Electrode	Lectromedics, Inc.	GXY	Class II	1988-11-15
K882061	Olympus Gf-Um3/eu-M3	Olympus Corp.	GDB	Class II	1988-11-15
K881056	Amresco Flow Pac Random Access Liquid #4901030	American Research Products Co.	JJC	Class I	1988-11-15
K884584	Tongue Seizing Forceps with & without Rubber Pads	Eastmed Enterprises, Inc.	BWB	Class I	1988-11-14
K884553	Stamey Needle	Cook Ob/Gyn	GEJ	Class I	1988-11-14
K884418	Premier Die-Trak Articulator	Premier Medical	EJP	Class I	1988-11-14
K884264	High Risk Needle Connector Assembly	Venture Molded Products, Inc.	FPA	Class II	1988-11-14
K884156	Hyperbaric Intravenous Infusion Extension Set	Sechrist Industries Inc	FPK	Class II	1988-11-14
K884086	C100 Qt Variable Height Adjustment Incubator	Air-Shields Vickers, Inc.	FMZ	Class II	1988-11-14
K883779	Wallaby(tm) Blanket	Fiberoptic Medical Products, Inc.	LBI	Class II	1988-11-14
K883773	H.a.c. Model-B (All in the Canal)	Hearing Aid Crafters	ESD	Class I	1988-11-14
K883772	H.a.c. Model-a (All in the Ear)	Hearing Aid Crafters	ESD	Class I	1988-11-14
K883768	Vas-Cath Catheter Repair Kit	Vas-Cath, Inc.	LFJ	Class II	1988-11-14
K883756	Toshiba Mrt-50A Magnetic Resonance System	Toshiba Medical Systems	LNH	Class II	1988-11-14
K883705	Face Mask: Comas Also Choice/cone Mask: Polymas	Select Sources, Inc.	FXX	Class II	1988-11-14
K883667	Donaldson Ventilation Tubes Pt. # Ag/s9	Exmoor Plastics Limited	ETD	Class II	1988-11-14
K883120	Flex Plastic Plastic Coated Nitinol Arch Wire	Flexmedics	EJF	Class I	1988-11-14
K882391	Opus 3 Pulse Generators Models 4003,4004,4023,4024	Ela Medical, Inc.	DXY	Class III	1988-11-14
K881917	Fluidair	KCI USA, Inc.	INX	Class II	1988-11-14
K881866	Needle Remover	Howard, Hills & Harsh	FMF	Class II	1988-11-14
K873766	Sternal Power Awl	Bowen & Company, Inc.	KIJ	Class I	1988-11-14
K884549	Alkaline Phosphatase Test (Alp) Item No. 65651	Em Diagnostic Systems, Inc.	CJE	Class II	1988-11-10
K884548	Lactate Dehydrogenase Test (Ld) Item No. 65668	Em Diagnostic Systems, Inc.	CFJ	Class II	1988-11-10
K884545	Delfia (Tm) Hige Kit	Pharmacia, Inc.	DGC	Class II	1988-11-10
K884181	Manual Surgical Instruments (Several Models)	Sales & Marketing Assoc.	GEN	Class I	1988-11-10
K884108	Macropore Medical/surgical Paper Tape	Lectec Corp.	KGX	Class I	1988-11-10
K884100	Amerlite Progesterone Assay, Lan.0079/2079 240/144	Amersham Corp.	JLS	Class I	1988-11-10
K884021	Emds Glucose (Gluc) Testpacks, No. 67697/95	Em Diagnostic Systems, Inc.	CFR	Class II	1988-11-10
K883972	Magnesium Reagent (Magon Sulfonate)	Sigma Chemical Co.	JGJ	Class I	1988-11-10
K883942	Hycor Sentry Drugs of Abuse Urine Control	Icl Scientific	JJY	Class I	1988-11-10
K883816	Shoulder Microstructured Humeral Prosthesis	Osteonics Corp.	KWS	Class II	1988-11-10
K883813	Ciba Corning Blood Collection Capillary Tube	Ciba Corning Diagnostics Corp.	JKA	Class II	1988-11-10
K883749	Probe(tm) Models 700 and 1000	Packard Instrument Co., Inc.	JQW	Class I	1988-11-10
K883621	Instrumentarium Ulf Mr Imaging System	Instrumentarium Corp.	LNH	Class II	1988-11-10
K883019	Saturne 42 and 43	General Electric Co.	IYE	Class II	1988-11-10
K882923	Kodak Surecell Chlamydia Test Kit	Eastman Kodak Company	LJC	Class I	1988-11-10
K882570	Turbox Theophylline Assay	Unipath, Ltd.	LER	Class II	1988-11-10
K882192	Hygeia Urine Pregnancy Test	Hygeia Sciences	DHA	Class II	1988-11-10
K881426	Pan-Pra Aid Self-Adhe. Collo. Coated Bandage	Laboratoire Pan-Pra	NAD	Class I	1988-11-10