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 892 of 3530

510(k) clearances, page 892 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K121342	Xia 4.5 Spinal System	Stryker Corp.	NKB	Class II	2012-06-22
K121222	Trek Otw Coronary Dilatation Catheter Mini Trek Otw Coronary Dilatation Catheter	Abbott Vascular	LOX	Class II	2012-06-22
K121018	Bioraptor 2.9, Bioraptor 2.3 Pk, Osteoraptor, & Bioraptor Knotless Suture an	Smith & Nephew, Inc.	MBI	Class II	2012-06-22
K120975	Cs 8100 Cs 8100 Access	Trophy	MUH	Class II	2012-06-22
K120959	Bioplex 2200 Hsv-1 and Hsv-2 Igg Kit	Bio-Rad Laboratories Inc.	MXJ	Class II	2012-06-22
K120690	Insulin Pen Needle	Tiger Medical Products, Ltd.	FMI	Class II	2012-06-22
K120472	Quantra	Hologic, Inc.	LLZ	Class II	2012-06-22
K120415	Cryo-Touch III	Myoscience, Inc.	GXH	Class II	2012-06-22
K120342	EMG Recording Electrode Assembly	Rhythmlink International, LLC	IKT	Class II	2012-06-22
K113873	Pentax Epk-I5020 Video Processor	PENTAX of America, Inc.	FET	Class II	2012-06-22
K112975	Carbonaid C02 Diffuser	Cardia Innovation AB	HIF	Class II	2012-06-22
K112827	Sheathes Ultrasond Gel	Sheathing Technologies Inc	MUI	Class II	2012-06-22
K112805	Kimguard One-Step Sterilization Wrap	Kimberly-Clark Corporation	FRG	Class II	2012-06-22
K112414	Elia B2-Glycoprotein I Iga Immunoassay	Phadia AB	MSV	Class II	2012-06-22
K121675	Versavit	Synergetics Inc	HQE	Class II	2012-06-21
K121521	Axera Access System	Arstasis, Inc.	DYB	Class II	2012-06-21
K121378	Airtraq Sp Airtraq Avant	Prodol Meditec S.A.	CCW	Class I	2012-06-21
K121367	Zoll Propaq Xm	ZOLL Medical Corporation	MHX	Class II	2012-06-21
K121165	Beam Brush/beam App	Beam Technologies, LLC	EFW	Class I	2012-06-21
K121032	Primary Symbiq Set, Dital Microbore Tubing, 0.2 Micron Filter, Non-Dehp	Abbott Medical	FPA	Class II	2012-06-21
K121031	Wavelight Fs200 Patient Interface 1505	Alcon Laboratories	GEX	Class II	2012-06-21
K121028	Etview Tracheoscopic Ventilation Tube (Tvt(tm))	Etview, Ltd.	BTR	Class II	2012-06-21
K120524	Sphincter of Oddi Manometric (Som) System	Mui Scientific	FFX	Class II	2012-06-21
K120339	Procoll	Innocoll Pharmaceuticals	KGN	Unclassified	2012-06-21
K120247	Easydex	Vineland Syrup Inc.	MRV	Class II	2012-06-21
K120245	Playtex Gentle Glide Scented Tampons and Playtex Gentle Glide Unscented Tampons	Playtex, Inc.	HIL	Class II	2012-06-21
K113566	Optmizer Cts T-Cell Expansion Serum Free Medium	Life Technologies Corporation	NDS	Class II	2012-06-21
K113277	Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter Kits	Arrow International LLC (subsidiary of Teleflex Incorporated)	LJS	Class II	2012-06-21
K112824	Quality Life Technologies Compressor Nebulizer	Quality Life Technologies Co., Ltd.	CAF	Class II	2012-06-21
K121588	Randox Cystatin C Control Level 2 Randox Cystatin C Control Level 3	Randox Laboratories, Limited	JJX	Class I	2012-06-20
K121534	Cone-Trol Hemoglobin A1c Control Set	Cone Bioproducts	JJX	Class I	2012-06-20
K121530	Bodyfix System	3C-Medical Intelligence GmbH	IYE	Class II	2012-06-20
K121493	Ascend Shoulder System	TORNIER Inc.	KWS	Class II	2012-06-20
K121403	Continuous Peripheral Nerve Block Catheter Kit and Set	Teleflex Medical	CAZ	Class II	2012-06-20
K120916	Qfix Radiotherapy Chair	Anholt Technologies Inc.	JAI	Class II	2012-06-20
K120877	Micromanipulator Set	Narishige Co., Ltd.	MQJ	Class II	2012-06-20
K120783	Able-X	Im-Able, Ltd.	ION	Class I	2012-06-20
K120702	E.g. Scan II Esphagoscope System	IntroMedic Co., Ltd.	EOX	Class II	2012-06-20
K120567	Gyrus Amci Pk Button Electrode	Gyrus ACMI, Inc.	FAS	Class II	2012-06-20
K120447	X4	Advanced Brain Monitoring, Inc.	OMC	Class II	2012-06-20
K120418	Electrosugrical Resection and Vaporization Electrode Series	Olympus Winter & Ibe GmbH	FAS	Class II	2012-06-20
K120048	Drfp Propoints, Propoints 4%, Propoints 6%, Propoints Pt, Propoints S	Drfp, Ltd.	KIF	Class II	2012-06-20
K113310	Endogater Avantage CO2 Insufflator	Byrne Medical, Inc.	FCX	Class II	2012-06-20
K112809	Blue Mountain Cervical Plate	Qualgenix	KWQ	Class II	2012-06-20
K112024	Ti-Max X450	Nakanishi Inc.	EFB	Class I	2012-06-20
K121250	Op Spine System	Orthopediatrics Corp	OSH	Class II	2012-06-19
K121024	Linear Porous Coated Hip Stem, Size 5; Revelation Hip Stem, Size 8; Foundation Porous Press Fit Stem, Size 8;	Encore Medical, LP	LPH	Class II	2012-06-19
K120286	Trojan Her Pleasure (Ribbed) Ecstasy Latex Condom with Lubricant	Church & Dwight Co., Inc.	HIS	Class II	2012-06-19
K113668	Healite II System	Lutronic Corporation	ILY	Class II	2012-06-19
K113033	Sodium Chlorde Inhalation Solution, 0.9% Usp-3Ml	Nephron SC, LLC.	CAF	Class II	2012-06-19