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 2026-11-02, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2408 of 3531

510(k) clearances, page 2408 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K914181	Wang/mill-Rose Transbronchial Aspiration Needle	Mill-Rose Laboratory	EOQ	Class II	1991-12-10
K914067	Retrieval Device	Target Therapeutics	DQO	Class II	1991-12-10
K912262	Hexlock	Imtec Corp.	DZE	Class II	1991-12-10
K911963	Medtronic Model 90002065 Mf TENS System	Medtronic, Inc.	GZJ	Class II	1991-12-10
K910815	Cr Spiral Electrode	Neward Enterprises, Inc.	HGP	Class II	1991-12-10
K903148	Challenge 3000 Neurological Booster	Maximum Performance Technologies, Mpts, Inc.	IPF	Class II	1991-12-10
K915194	Cedia T4	Boehringer Mannheim Corp.	KLI	Class II	1991-12-09
K915179	Phencyclidine Eia Assay	Diagnostic Reagents, Inc.	LCM	Unclassified	1991-12-09
K914850	Chemiluminescent System Allergan Specific Ige	Mast Immunosystems	DHB	Class II	1991-12-09
K914830	A101 Litessager	Fairform Mfg., Co., Ltd	IRO	Class I	1991-12-09
K914829	Fo92 Seating Massager	Fairform Mfg., Co., Ltd	IRO	Class I	1991-12-09
K914801	Immunowell Dsdna Antibody Test	General Biometrics, Inc.	DHC	Class II	1991-12-09
K914782	Suction/irrigation Probe	O.R. Concepts, Inc.	GCJ	Class II	1991-12-09
K914781	Suction/irrigation Kittner	O.R. Concepts, Inc.	GCJ	Class II	1991-12-09
K914707	F055 B.o. Fantastic Relaxer	Fairform Mfg., Co., Ltd	IRO	Class I	1991-12-09
K914706	Fo51/f151 Golf Massager	Fairform Mfg., Co., Ltd	IRO	Class I	1991-12-09
K914705	Fo41 Body Massager	Fairform Mfg., Co., Ltd	IRO	Class I	1991-12-09
K914704	Fo69 Fancy Massager	Fairform Mfg., Co., Ltd	IRO	Class I	1991-12-09
K914703	F383 Rechargeable Mini Massager	Fairform Mfg., Co., Ltd	IRO	Class I	1991-12-09
K914693	Depuy (Nitino) Guide Wire	Depuy, Inc.	JDQ	Class II	1991-12-09
K914505	Stone Basket	Surgitek Medical Engineering Corp.	FFL	Class II	1991-12-09
K914458	Escort 300A Series Defibrillator/pacer Option	Medical Data Electronics	LDD	Class II	1991-12-09
K914390	Transferrin Rid Kit	The Binding Site	DDG	Class II	1991-12-09
K914307	Spectrolyse Protein C Kit	Biopool AB	GGP	Class II	1991-12-09
K914245	Dale(r) Nasal Dressing Holder (Product No. 600)	Dale Medical Products, Inc.	KGX	Class I	1991-12-09
K914186	Ultracrown(tm) Pre-Solder	Dentsply Intl.	EJT	Class II	1991-12-09
K914062	Nk Dexteritly Board, Model Bx001	Nk Biotechnical Engineering Co.	KQX	Class I	1991-12-09
K914061	Nk Range of Motion Sensor, Model Rm002	Nk Biotechnical Engineering Co.	KQX	Class I	1991-12-09
K914060	Range of Motion Sensor, Model Rm001	Nk Biotechnical Engineering Co.	KQX	Class I	1991-12-09
K914059	Nk Deviation Sensor, Model Dv001	Nk Biotechnical Engineering Co.	LBB	Class II	1991-12-09
K914057	Nk Pinch Sensor, Model Pa001	Nk Biotechnical Engineering Co.	LBB	Class II	1991-12-09
K914056	Nk Pinch Sensor, Model Pf002	Nk Biotechnical Engineering Co.	LBB	Class II	1991-12-09
K914055	Pinch Sensor, Model Pf001	Nk Biotechnical Engineering Co.	LBB	Class II	1991-12-09
K914054	Nk Grasp Sensor, Model Gr001	Nk Biotechnical Engineering Co.	LBB	Class II	1991-12-09
K914051	Pediatric Vitrectomy Lens Set	Ocular Instruments, Inc.	HJK	Class II	1991-12-09
K914043	Midwest Implant Hexed 3.75Mm Standard Thread Impla	Midwest Implant Sales, Inc.	DZE	Class II	1991-12-09
K914042	Midwest Implant Hexed 3.75Mm Self Tapping Implant	Midwest Implant Sales, Inc.	DZE	Class II	1991-12-09
K914041	Midwest Implant Hexed 3.3 Mm Cylinder Type Implant	Midwest Implant Sales, Inc.	DZE	Class II	1991-12-09
K914038	Polly's Cutter J-225	O.R. Specialties, Inc.	HQE	Class II	1991-12-09
K914029	Esophageal Z-Stent	Cook Inc.	ESW	Class II	1991-12-09
K913916	Hydroxylapatite Coated Ti-Fit Femoral Component	Smith & Nephew Richards, Inc.	MEH	Class II	1991-12-09
K913887	C02 Laser Waveguide	Heraeus Lasersonics, Inc.	GEX	Class II	1991-12-09
K913811	Fukuda Denshi Model Fcp-4101	Fukuda Denshi USA, Inc.	LOS		1991-12-09
K913670	Haptoglobin Immunological Test Kit	The Binding Site	DAB	Class II	1991-12-09
K913666	Alpha-1-Antitrypsin Immunological Nl Test Kit	The Binding Site	DEM	Class II	1991-12-09
K913604	Somatosensory Stimulus System	Biomagnetic Technologies, Inc.	GZP	Class II	1991-12-09
K912842	Rsv-Mab Test	Gull Laboratories, Inc.	LKT	Class I	1991-12-09
K912744	Org-8200A Universal Signal Housing	Nihon Kohden America Inc	DSI	Class II	1991-12-09
K912701	Dantec Menuet	Dantec Medical, Inc.	FAP	Class II	1991-12-09
K912682	Orthodontic Headgear	K-Tek Orthodontic Products	DZB	Class II	1991-12-09