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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3189 of 3528

510(k) clearances, page 3189 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K822791	Coratomic #Vx5-105 & Vx5-205 Pulse Gen.	Coratomic, Inc.	DXY	Class III	1982-12-15
K821702	Power Suture	Taylor H. Haynes, M.D.			1982-12-15
K821669	Ames Tda Gentamicin Test	Miles Laboratories, Inc.	DJB	Class II	1982-12-15
K828595	Maxicamera 300A Small Field of View Imaging System	General Electric Co.			1982-12-14
K828586	Entrekin Model Dx-300 Continuous Wave Ultrasonic Doppler Transducer	Cranbury Medical Labs, Inc.			1982-12-14
K827176	Model 640 Linear Scanner	GE Medical Systems Information Technologies, Inc.			1982-12-14
K823353	Carcino-Cek	Biologics Intl., Inc.	JJX	Class I	1982-12-14
K823277	The Progressive Chair	Progressive Productions, Ltd.	INN	Class I	1982-12-13
K822924	Ministim 180	Micron Instruments, Inc.	IPF	Class II	1982-12-13
K822916	Urocomp Remote Control 1804	Life-Tech Intl., Inc.	FAP	Class II	1982-12-13
K822812	Ysi Model 23L Lactate Analyzer	Yellow Springs Instrument Co., Inc.	HHP	Class II	1982-12-13
K822681	Anti-Nuclear Antibody Test Kit (Ana)	Amico Lab, Inc.	DHN	Class II	1982-12-13
K823506	Nasal Cannula	Seven Harvest Intl. Import & Export	CAT	Class I	1982-12-09
K823492	Birt-a-Pad #730	Birtcher Corp.			1982-12-09
K823483	Stainless Steel Pistons	Humboldt Products	ETB	Class II	1982-12-09
K823437	Mcgee 26Ga. Suction Tube	Treace Medical, Inc.	EQH	Class I	1982-12-09
K823436	Microsurgical Gauge	Treace Medical, Inc.	EQH	Class I	1982-12-09
K823417	Prisma-C-Reactive Protein Calibrators	Syva Co.	DCK	Class II	1982-12-09
K823416	Prisma C-Reactive Protein Assay	Syva Co.	DCK	Class II	1982-12-09
K823415	Prisma C-Reactive Protein Controls	Syva Co.	DCK	Class II	1982-12-09
K823384	Hearing Aid Hb-72 Rionet	Kindel & Anderson	ESD	Class I	1982-12-09
K823383	Hearing Aid Hb-33 Rionet	Kindel & Anderson	ESD	Class I	1982-12-09
K823374	Oxygen Monitor Il 408	Instrumentation Laboratory Co.	CCL	Class II	1982-12-09
K823351	Central Venous Catheter	Plasmedics, Inc.	FOZ	Class II	1982-12-09
K823302	Cholesterol Chod-Pap Test	Boehringer Mannheim Corp.	CHH	Class I	1982-12-09
K823287	Respiratory Circuit Adaptor	Thoratec Laboratories Corp.	BZO	Class I	1982-12-09
K823265	Monoclonal Antibody T4 Radio-Kit	BD Becton Dickinson Vacutainer Systems Preanalytic	CDX	Class II	1982-12-09
K823257	Non-Reusable Universal Nebulizer Filte	Ohio Medical Products	CAH	Class II	1982-12-09
K823208	Mystik Autoclave Tape	Mystik Corp.	JOJ	Class II	1982-12-09
K823131	Koagulab 40-a Automated Coagulation Sys	Ortho Diagnostic Systems, Inc.	KQG	Class II	1982-12-09
K823058	Dosometric Release Sterilization	Stan-Pak Ent.	EFQ	Unclassified	1982-12-09
K823044	Km-Kal L3	Kmn Products, Inc.	JIX	Class II	1982-12-09
K822942	Innotron Fluorimeter Series One-10	Innotron of Oregon, Inc.	KHO	Class I	1982-12-09
K822898	Dsl 1600	Diagnostic Systems Laboratories, Inc.	CIA	Class II	1982-12-09
K822734	Ebv Igm Test	Gull Laboratories, Inc.	JRY	Class I	1982-12-09
K821736	Echo-Pulse Km555	Rabar, Inc.	GXW	Class II	1982-12-09
K821505	Airway Temperature Sensor	Mon-A-Therm, Inc.	GEI	Class II	1982-12-09
K823408	Be#1000-Instant On/off O2 Valve	Instrumentation Industries, Incorporated	BTM	Class II	1982-12-07
K823375	Nephross, Andante h.f.	bioMerieux, Inc.	KOC	Class II	1982-12-07
K823327	Portable Shower Bath	Wall Manufacturer, Inc.	ILM	Class II	1982-12-07
K823274	Uni-Tip Colostomy Irrigation Cone	Howmedica Corp.	EXD	Class II	1982-12-07
K823232	Ysi #2650 Single-Display Oxygen & Temp	Yellow Springs Instrument Co., Inc.	CCL	Class II	1982-12-07
K823231	Ysi #2600 Multi-Channel Dual-Display	Yellow Springs Instrument Co., Inc.	CCL	Class II	1982-12-07
K823140	Electroencephalograph	Nihon Kohden America Inc	GWQ	Class II	1982-12-07
K823116	Neurotrac	Interspec, Inc.	GWQ	Class II	1982-12-07
K823083	Electrosurgical Unit	Kelleher Corp.	GEI	Class II	1982-12-07
K822713	Derm-a-Tec Skin Barrier Film	Professional Medical Products, Inc.			1982-12-07
K823485	Sure Snip	South Mountain Medical	EFQ	Unclassified	1982-12-03
K823468	Model H 37E	Marcon Hearing Instruments, Inc.	ESD	Class I	1982-12-03
K823460	Models G6h, G6t, G1h & G1t	Widex Hearing Aid Co., Inc.	ESD	Class I	1982-12-03