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 2229 of 3531

510(k) clearances, page 2229 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931578	Texas Scottish Rite Easy/lock Fixator	Applied Osteo Systems, Inc.	JEC	Class II	1994-02-22
K931512	Sunglasses	Alpina U.S.A. Eyewear, Inc.	HQY	Class I	1994-02-22
K931497	Sunglasses	Wain Lin Trading Corp.	HQY	Class I	1994-02-22
K931472	Careject Disposable Syringe and Needle	Carewell Mediproducts, Ltd.	FMF	Class II	1994-02-22
K931425	Surgical Patch Spreader	General Surgical Innovations	GCJ	Class II	1994-02-22
K931358	Aorp4000 Reusable Pak	American Optical Corp.	HQC	Class II	1994-02-22
K931354	P4000 Phacoemulsifier	American Optical Corp.	HQC	Class II	1994-02-22
K931246	Cerclage Wire Crimp Sleeve	Acu Med, Inc.	JDQ	Class II	1994-02-22
K931203	Cool-Aid	Seabrook Medical Systems, Inc.	ILO	Class II	1994-02-22
K930833	Pca(r) Solid Back Acetabula Shell	Howmedica Corp.	JDL	Class III	1994-02-22
K930788	Zirconia Ceramic Femoral Head	Smith & Nephew Richards, Inc.	LZO	Class II	1994-02-22
K930615	Autovac Closed Wound Suction System	Boehringer Laboratories, LLC	GCY	Class I	1994-02-22
K930584	Magnacore	Scientific Pharmaceuticals, Inc.	EBF	Class II	1994-02-22
K930583	Megabond System	Scientific Pharmaceuticals, Inc.	EBF	Class II	1994-02-22
K930507	Custom Orthopaedic Trays (Packs)	Associated Medical Products Co.	HTS	Class I	1994-02-22
K930460	Howmedica Revision Hip System	Howmedica Corp.	JDI	Class II	1994-02-22
K930223	Howmedica Acetabular Shell	Howmedica Corp.	JDI	Class II	1994-02-22
K930156	Mega Plus Super Lag Screw	Pfizer Hospital Products Group, Inc.	KTT	Class II	1994-02-22
K930144	The Scitech One-Day Filter	Scitech Solutions, Inc.	EIA	Class I	1994-02-22
K930107	Ame Universal Bone Screw	American Medical Electronics, Inc.	HWC	Class II	1994-02-22
K926353	Flowgel(r) Topical Wound Dressing	Mediventures, Inc.	MGQ	Unclassified	1994-02-22
K926229	Apc Femoral Component	Howmedica Corp.	JDI	Class II	1994-02-22
K926228	Duracon Cruciform Tibial Baseplate	Howmedica Corp.	JWH	Class II	1994-02-22
K925531	Solarshield Clips	Dioptics Medical Products, Inc.	HQY	Class I	1994-02-22
K925403	Baxter Apd 12' Extension Line	Baxter Healthcare Corporation	KDJ	Class II	1994-02-22
K925172	Pca(r) E Series Hip System (Cementless Use)	Howmedica Corp.	LPH	Class II	1994-02-22
K924482	Howmedical Total Knee Stem Extender	Howmedica Corp.	JWH	Class II	1994-02-22
K924403	Control Plasma N	Behring Diagnostics, Inc.	GIZ	Class II	1994-02-22
K924402	Control Plasma U	Behring Diagnostics, Inc.	GGC	Class II	1994-02-22
K924401	Pathoplasma(r) I & II (Path Citrated Human Plasma)	Behring Diagnostics, Inc.	GGC	Class II	1994-02-22
K924200	Reflex(r) Esc	Richard-Allan Medical Ind., Inc.	KNF	Class II	1994-02-22
K923628	Cervical Loop Electrode & Rollerball Electrode	Bruce Mclucas	HGI	Class II	1994-02-22
K922071	Zimmer Anatomic Hip System	Zimmer GmbH	LPH	Class II	1994-02-22
K921557	Bias Total Hip System Acetabular Component	Zimmer GmbH	LPH	Class II	1994-02-22
K921308	Hg Multilock Hip Prosthesis W/ Ti-Nidium	Zimmer GmbH	LPH	Class II	1994-02-22
K920514	Spiral	Thornton Associates, Inc.	HIS	Class II	1994-02-22
K914145	Dsd-91(Tm) Disinfector for Flexible Endoscopes	Medivators Inc	FEB	Class II	1994-02-22
K934549	All-Vue Ultra-Lite Thin Wall Syringe Shield	Victoreen, Inc.	IWR	Class I	1994-02-19
K935870	Dextren Powder Free Hypoallerg Gloves W/o Colorants	BD Becton Dickinson Vacutainer Systems Preanalytic	KGO	Class I	1994-02-18
K935669	Syrigene Pre-Filled Syringe	Regulatory & Marketing Services, Inc.	JDL	Class III	1994-02-18
K935539	Capintec Crc 35R	Capintec Instruments, Inc.	KPT	Class II	1994-02-18
K935299	Astroglide	Biofilm, Inc.	KMJ	Class I	1994-02-18
K935297	Stryker Ambulance Cot Model 6060	Stryker Medical	FPO	Class II	1994-02-18
K935286	Quantaphase II B12/folate	Bio-Rad	CGN	Class II	1994-02-18
K935252	K-Lok Catheter Securement Device Modification	K-Lok, Inc.	KMK	Class I	1994-02-18
K935247	Jedmed Compact Endoscopic Beamsplitter	JEDMED Instrument Company	FEA	Class I	1994-02-18
K935046	Gx-770 X-Ray Control, Model 46-404600G4	Gendex Corp.	EHD	Class II	1994-02-18
K934766	Carbon Fiber Pallet	Siemens Gammasonics, Inc.	IYX	Class I	1994-02-18
K934758	R2+	Jeneric/Pentron, Inc.	EJH	Class II	1994-02-18
K934588	Chloride (Mf) Assay	Sekisui Diagnostics P.E.I. Inc.	CHG	Class II	1994-02-18