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 3137 of 3528

510(k) clearances, page 3137 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K832557	Fertitell Direct Pregnancy Test #1100	Stanbio Laboratory	JHJ	Class II	1983-09-12
K832556	Neonatal Lumbar Puncture Tray	American Pharmaseal Div. Ahsc	FMI	Class II	1983-09-12
K832537	Conveen Leg Bag W/tube-Drainage Bag	Telcam Medical Devices, Inc.	KNX	Class II	1983-09-12
K832527	Pregna-Tec	Medilab Corp.	JHJ	Class II	1983-09-12
K832505	Image Processing Sys A3	Metronic, Inc.	IYX	Class I	1983-09-12
K832504	Cronex Lo-Dose Mammography	E.I. Dupont de Nemours & Co., Inc.	IWZ	Class I	1983-09-12
K832503	Clinac 1800	Varian Assoc., Inc.	IYE	Class II	1983-09-12
K832502	Electron Beam Option for Clinac 15 Mev	Varian Assoc., Inc.	IYE	Class II	1983-09-12
K832499	Phase II Tsh Kit	Medical & Scientific Designs, Inc.	JLW	Class II	1983-09-12
K832496	Bio Sure Stain	Helena Laboratories, Corp.	IDA	Class I	1983-09-12
K832493	Quinidine Fluorescent Immunoassay	American Diagnostic Corp.	LBZ	Class II	1983-09-12
K832489	Conveen Drip Collector/net Pants	Telcam Medical Devices, Inc.	EYQ	Class I	1983-09-12
K832480	Trust Rpr Titration Card Test #65145	EMD Millipore Corporation	GMQ	Class II	1983-09-12
K832479	Trust Rpr Card Test #65144	EMD Millipore Corporation	GMQ	Class II	1983-09-12
K832471	Adjustable Pharyngeal Airway/berman III	Inmed Corp.	CAE	Class I	1983-09-12
K832469	T3-Ria Single Reagent	Fairlake Laboratories	CDP	Class II	1983-09-12
K832468	T4-Ria Single Reagent	Fairlake Laboratories	CDX	Class II	1983-09-12
K832463	Raichem Alkaline Phosphatase Reagent	Reagents Applications, Inc.	CJE	Class II	1983-09-12
K832462	Autopak Neonatal Tsh Ria Kit	Micromedic Systems	JLW	Class II	1983-09-12
K832460	Triglyceride Reagent-Trinder-Gpo	Seppim, Inc.	JGY	Class I	1983-09-12
K832457	A-Gent Phenobarbital	Abbott Medical	DLZ	Class II	1983-09-12
K832452	Androstenedione Test Set 125I	Wien Laboratories, Inc.	CIZ	Class I	1983-09-12
K832447	Stratus Carbamazepine Flurometric	American Dade	KLT	Class II	1983-09-12
K832443	Ultrasonic Dental Prophylaxis Unit	California Technics, Inc.	ELC	Class II	1983-09-12
K832426	Easytouch Triglycerides Reagent Set	Worthington Diagnostic Systems	CDT	Class I	1983-09-12
K832424	Envision G31 P.e. Pak	Envision, Inc.	HQC	Class II	1983-09-12
K832423	Envision G21 I/a Enpak	Envision, Inc.	HQC	Class II	1983-09-12
K832418	Ohio Temperature Simulator	Airco/Ohio Medical Products	FMZ	Class II	1983-09-12
K832415	Deproteinizing & Cleaning Solution	Shaban Mfg. Co.	JGS	Class II	1983-09-12
K832411	Gasline Filter #Gf-10	American Bentley	KRI	Class I	1983-09-12
K832410	Graseby Dynamics Ms302 Syringe Driver	Intermedics, Inc.	FRN	Class II	1983-09-12
K832404	Rectal Temp. Telemetry Monitor	Xomed, Inc.	FLL	Class II	1983-09-12
K832392	Sdc Oral-Rectal Temp. Probe	Science Development Corp.	FLL	Class II	1983-09-12
K832391	Qt-100 Electronic Temp. Monitor	Science Development Corp.	FLL	Class II	1983-09-12
K832387	Denture Cleaner	Tower Laboratories Ltd	JER	Class I	1983-09-12
K832385	Cryoprobes Mc-1400-Cryosurg-Console	Spembly Medical, Ltd.	GEH	Class II	1983-09-12
K832347	Twofer Needle	Baxa Corp., Sub. of Cook Group, Inc.	LHI	Class II	1983-09-12
K832342	Endoscopic Camera Tv W/audio	Kamiya Tsusan Kaisha, Ltd.	KQM	Class I	1983-09-12
K832332	Vented i.v. Transfer Needle	Baxa Corp., Sub. of Cook Group, Inc.	LHI	Class II	1983-09-12
K832312	i.v. Transfer Needle	Baxa Corp., Sub. of Cook Group, Inc.	LHI	Class II	1983-09-12
K832293	Enternal Feeding Tube	Concept, Inc.	KNT	Class II	1983-09-12
K832289	Lifecare Micro Pump	Abbott Medical	FRN	Class II	1983-09-12
K832271	Emerson Model 3Mv-Ap and 3V-Ap Press-	J. H. Emerson Co.	CAP	Class II	1983-09-12
K832216	Varian Clinacomp 100 Tissue Compensator	Varian Assoc., Inc.	IYE	Class II	1983-09-12
K832190	Metavox Mv-1000 Auditory Trainer	Metavox, Inc.	EPF	Class II	1983-09-12
K832176	Negative Pressure Chest Respirator Pump	J. H. Emerson Co.	BYT	Class II	1983-09-12
K832113	Normac Anesthetic Agent Monitor	Datex Division Instrumentarium Corp.	CBS	Class II	1983-09-12
K832105	Administrative IV Set	Lee Medical Intl., Inc.	FPA	Class II	1983-09-12
K832104	Sterile Disp. Butterfly Infusion Set	Lee Medical Intl., Inc.	FPA	Class II	1983-09-12
K832101	Sterile Disposable Syringe	Lee Medical Intl., Inc.	FMF	Class II	1983-09-12