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 2026-11-05, 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 2011 of 3531

510(k) clearances, page 2011 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K954247	Syscon Control Assayed & Unassayed	Scantibodies Laboratory Inc.	JJY	Class I	1996-02-14
K953807	Daily Wear Soft (Hydrophilic) Contact Lens	Stephen A. Dunn, Inc.	LPL	Class II	1996-02-14
K953230	CPR Super Pocket Pack	Formosa-Cj Health Business Corp.	CBP	Class II	1996-02-14
K952776	Lfic or Fetto Hip	Zimmer GmbH	LWJ	Class II	1996-02-14
K952667	Chrom Z-Heparin, Cat. No 5242	Helena Laboratories, Corp.	KFF	Class II	1996-02-14
K951846	Mirage Spinal System for Severe Spondylolisthesis	Alphatec Spine, Inc.	KWP	Class II	1996-02-14
K951208	Rota-Dan Rapid Rotavirus Eia Kit	Eldan Technologies, Ltd.	LIQ	Class I	1996-02-14
K950717	Augment-T Posterior Spinal System	Sofamor Danek USA,Inc.	MNH	Class II	1996-02-14
K950613	Keisei	Keisei (USA) Co., Ltd.	CAE	Class I	1996-02-14
K945028	Finn Knee System	Zimmer GmbH	KRO	Class II	1996-02-14
K943827	Spine Fixation	Danek Medical, Inc.	MNH	Class II	1996-02-14
K960336	Cardon Physical Therapy Table Model R27645	Cardon Rehabilitation Products, Inc.	INQ	Class I	1996-02-13
K960334	Cardon Physical Therapy Table Model R27116	Cardon Rehabilitation Products, Inc.	INQ	Class I	1996-02-13
K960332	Cardon Physical Therapy Table Model R28598	Cardon Rehabilitation Products, Inc.	INQ	Class I	1996-02-13
K960013	Mdc Safe Step Safety i.v. Catheter System	MDC Research, Ltd.	FOZ	Class II	1996-02-13
K955734	Lasersonics Parascan Dosimeter Device	Heraeus Surgical, Inc.	GEX	Class II	1996-02-13
K955623	Olympus Bipolar Forceps	OLYMPUS Corporation of the Americas	GEI	Class II	1996-02-13
K955474	Neo-Pneumocath	Intra Special Catheters GmbH	GBX	Class I	1996-02-13
K955466	Dynameq-II Option	Qualitone	ESD	Class I	1996-02-13
K955228	Sas Spicer-Edwards L Complex	SA Scientific, Ltd	GNC	Class II	1996-02-13
K955227	Sas Spicer-Edwards En Complex Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-13
K955226	Sas Spicer-Edwards 4 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-13
K955225	Sas Spicer-Edwards 3 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-13
K955224	Sas Spicer-Edwards 2 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-13
K955223	Sas Spicer-Edwards 1 Antiserum	SA Scientific, Ltd	GNC	Class II	1996-02-13
K955222	Sas Spicer-Edwards 1 Complex	SA Scientific, Ltd	GRM	Class II	1996-02-13
K954877	Omni Cold Gel Packs	Omni Therm, Inc.	IMD	Class I	1996-02-13
K953847	Roche Reagent for Glucose	Roche Diagnostic Systems, Inc.	CFR	Class II	1996-02-13
K953634	Shimasonic Sdu-350 Electronic Linear/convex Diagnostic Ultrasound System	Shimadzu Medical Systems	IYO	Class II	1996-02-13
K952044	Insulcap	Karen Holtz	FMI	Class II	1996-02-13
K951848	Aia-Pack CPR Assay	Tosoh Medics, Inc.	JKD	Class I	1996-02-13
K943880	Ria Latex Condom	Mbf Personal Care Sdn. Bhd.	HIS	Class II	1996-02-13
K942852	Respitrace Pt	Non-Invasive Monitoring Systems, Inc.	DQK	Class II	1996-02-13
K942771	Respievents	Non-Invasive Monitoring Systems, Inc.	DQK	Class II	1996-02-13
K955878	Widex Model Senso Digital (C8)	Widex Hearing Aid Co., Inc.	ESD	Class I	1996-02-12
K955706	Jpi Automatic X-Ray Film Processor	JPI Healthcare Co., Ltd	IXW	Class II	1996-02-12
K955515	Alpha Micron 20 Microaggregate Filter	Alpha Therapeutic Corp.	CAK	Class II	1996-02-12
K955458	Ultrasound Probe Biopsy Accessories	Biosound, Inc.	ITX	Class II	1996-02-12
K955407	Port-a-Cath Dual Lumen Implantable Venous	Sims Deltec, Inc.	LJT	Class II	1996-02-12
K955245	Mentor Meridian Phacoemulsification System	Mentor O & O, Inc.	HQC	Class II	1996-02-12
K955235	B-D Ultra Fine II, Micro Fine + Short Needle Insulin Syringe	BD Becton Dickinson Vacutainer Systems Preanalytic	FMI	Class II	1996-02-12
K955139	Olympus Unsaturated Iron Binding Capacity Reagent	OLYMPUS Corporation of the Americas	JMO	Class I	1996-02-12
K954445	Non Applicator Tampon, Untreated	Hygieia Healthcare, Ltd.	HEB	Class II	1996-02-12
K954284	Medi-Plast 2 Port Manifold (Right on)	Medi-Plast Intl., Inc.	DTL	Class II	1996-02-12
K953648	A-V Impulse System Model 6060	Novamedix, Ltd.	JOW	Class II	1996-02-12
K952892	Olympus Ultrasonic Probe for Esophogus (Mh-908)	OLYMPUS Corporation of the Americas	ITX	Class II	1996-02-12
K950035	Surgiflator 20	W.O.M. GmbH	HIF	Class II	1996-02-12
K944940	Euro Sc500	Pride Health Care, Inc.	INI	Class II	1996-02-12
K960019	Retractor Arm Clamp	Biopsys Medical, Inc.	FWZ	Class I	1996-02-09
K955908	Boehringer Mannheim Igm Assay	Boehringer Mannheim Corp.	DAO	Class II	1996-02-09