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 2026-10-12, 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 3252 of 3528

510(k) clearances, page 3252 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K813587	Disposable Thoracic Catheter	Texas Medical Products, Inc.	GBS	Class I	1982-01-12
K813584	Clinitron Air Fluidized Support System	Uhi Corp.	INX	Class II	1982-01-12
K813583	Phonic Ear Model Pe805cd	Phonic Ear, Inc.	ESD	Class I	1982-01-12
K813567	Techmedia Bone Staple	Techmedica, Inc.	JDR	Class II	1982-01-12
K813554	Ace/kyle Captured Hip Screw	Ace Orthopedic Manufacturing Co.	KTT	Class II	1982-01-12
K813549	Continuous Flush Device	Namic	DRS	Class II	1982-01-12
K813546	Rionet Hearing Aid Hi-62	Rion Acoustic Instruments, Inc.	ESD	Class I	1982-01-12
K813545	Hyposermic Needles	Optical Micro Systems, Inc.	FMI	Class II	1982-01-12
K813542	Tobramycin Fluorescent Immunoassay	American Diagnostic Corp.	LCR	Class II	1982-01-12
K813541	Amikacin Fluorescent Immunoassay	American Diagnostic Corp.	KLQ	Class II	1982-01-12
K813537	Urifix	Isramed, Inc.	KNX	Class II	1982-01-12
K813528	Lens-Pac	The Plactory	HPX	Unclassified	1982-01-12
K813527	Dinamap Adult/ped./neonatal Vital Signs	Critikon Company, LLC	DXN	Class II	1982-01-12
K813526	Fecal Sanitary Tube	Leon'S Fecal Sanitary Tub Mfg.	KNT	Class II	1982-01-12
K813518	Implant Aid Splicing Crimp & Sleeve	Intermedics, Inc.	KFJ	Class III	1982-01-12
K813510	Cardiosonic Acoustic Amplifier	Srs Co.	LDE	Class I	1982-01-12
K813507	Infalert	Briox Technologies, Inc.	BZQ	Class II	1982-01-12
K813474	Maxill-Air Sinus Ventilation Tube	Xomed, Inc.	KAM	Class I	1982-01-12
K813453	Unit, Liquid, Oxygen, Portable	Pensee Medical Corp.	BYJ	Class II	1982-01-12
K813434	Electrosurgical Disp. Dispersive Pad	Promedicon, Inc.	KNS	Class II	1982-01-12
K813402	Wa-2000 Temperature Indicator	CooperSurgical, Inc.	FLL	Class II	1982-01-12
K813396	Verschlubstopfen Comb-Closing Stopper	Burron Medical Products, Inc.	FOZ	Class II	1982-01-12
K813345	Critikon i.v. Catheter Placement Unit	Critikon Company, LLC	FOZ	Class II	1982-01-12
K813180	Scotchbond Dental Adhesive	3M Company	KLE	Class II	1982-01-12
K812805	Steele's Econ. Pink Basepl. Waxes, I-III	Modern Materials	EGD	Class I	1982-01-12
K813335	Percutaneous Transhepatic Cholang. Tray	American Pharmaseal Div. Ahsc	FSH	Class I	1982-01-08
K812133	Wound Closure Instrument Tray	E.M. Adams Co., Inc.	FSM	Class I	1982-01-08
K813504	Acessory to Modified Freeding Jejunosto	Midwest Metabolic Support Group	KOA	Class I	1982-01-07
K813498	Medifix	Burron Medical Products, Inc.	KRK	Class II	1982-01-07
K813490	Version of a Closed-Flow Sys. Caloric	Thomas M. Foti, M.D.	ETF	Class I	1982-01-07
K813479	Argyle Pediatric Urine Collector	Sherwood Medical Co.	KNX	Class II	1982-01-07
K813468	Acc-U-Therm Temperature Monitor	Diatek, Inc.	FLL	Class II	1982-01-07
K813467	2002 Adjustable Flow Regulator	Safety Laboratories West	CAN	Class I	1982-01-07
K813466	4004 Constant Flow Regulator	Safety Laboratories West	CAN	Class I	1982-01-07
K813464	Disposable Transducer	Sorensen Research	DRS	Class II	1982-01-07
K813460	Chiba Skinny Needle	Ocean Medical Products, Ltd.	GAA	Class I	1982-01-07
K813448	Potts-Cournand Style Needle	Ocean Medical Products, Ltd.	GAA	Class I	1982-01-07
K813436	Oxycon	Home Medical Mfg., Co., Inc.	CAW	Class II	1982-01-07
K813418	Inzoma Np	J. Aderer, Inc.	EJS	Class II	1982-01-07
K813417	Inzoma P	J. Aderer, Inc.	EJT	Class II	1982-01-07
K813384	Disposable Neonatal Ventilation Circuit	Intec.	BZO	Class I	1982-01-07
K813376	Eye Charts	Abco Dealers, Inc.	HOX	Class I	1982-01-07
K813357	Caulk Opaquer	Dentsply Intl.	EBF	Class II	1982-01-07
K813352	Novametrix Model 816A Transcut. Oxygen	Novametrix Medical Systems, Inc.	KLK	Class II	1982-01-07
K813348	Yoshida Rido-F, Model Lm-01	Kaycor Intl., Ltd.	EKX	Class I	1982-01-07
K813132	The Chicago Gullet	Universal Prosthetics, Inc.	KNT	Class II	1982-01-07
K812958	East-Freeman Ventilator Mark 2	Cairco, Ltd.	CBK	Class II	1982-01-07
K813519	Non-Absorbent Towels	Cunningham Woodland, Inc.	KME	Class I	1982-01-05
K813480	Monoject M560 60Cc Syringes	Sherwood Medical Co.	FMF	Class II	1982-01-05
K813455	Pump & Detector	Medlog GmbH Marketing Services	FRN	Class II	1982-01-05