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 2163 of 3531

510(k) clearances, page 2163 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941860	Specialty Assayed Reference Plasma (S.a.r.p.)	Helena Laboratories, Corp.	GGN	Class II	1994-09-14
K941807	Intersect Systems' Non-Mercuric Chloride Reagent	Intersect Systems, Inc.	CHG	Class II	1994-09-14
K940961	Monoject Luer Adapter	Sherwood Medical Co.	FMI	Class II	1994-09-14
K940421	Sunglasses	Double Hero Corp.	HQY	Class I	1994-09-14
K934130	Swabzyme Oxidase	E-Y Laboratories, Inc.	JTO	Class I	1994-09-14
K932672	Mammomat 300 and Mammomat 3000	Siemens Medical Solutions USA, Inc.	IZH	Class II	1994-09-14
K932106	Mobilett Plus Mobile X-Ray System	Siemens Medical Solutions USA, Inc.	IZL	Class II	1994-09-14
K931077	Latex Prophylactic Rubber Contraceptive	J.K. Chemicals, Ltd.	HIS	Class II	1994-09-14
K926259	Surgimat	Novanta Medical GmbH	HET	Class II	1994-09-14
K944194	Disposable Heat & Mositure Exchanger & Filter/hme	Med-Tek Innovations, Inc.	BYD	Class I	1994-09-13
K944122	Dab Weldless Wheelchair	Da Intl., Ltd.	IOR	Class I	1994-09-13
K944104	Gabris Laparoscopic Surgical Kits	Gabris Surgical Corp.	FBQ	Class II	1994-09-13
K944082	Aslan Dual Action Jaws Grasping Forceps	Aslan Medical Technologies, Ltd.	GCJ	Class II	1994-09-13
K940731	Innervision Inc. Cannula/trocar,multiple Types	Innervision, Inc.	GCJ	Class II	1994-09-13
K940231	Intra-Aortic Balloon for Optional Sheathless Insertion	Datascope Corp.	DSP	Class II	1994-09-13
K944103	Laparoscopic/endoscopic Instrument	Gabris Surgical Corp.	GCJ	Class II	1994-09-12
K943989	Laparoscopic/endoscopic Instruement	Gabris Surgical Corp.	HFO	Class II	1994-09-12
K943388	Gc Surflex F	GC America Inc.	ELW	Class II	1994-09-12
K943111	Transparent Dressing	Acutek Adhesive Specialties, Inc.	MGP	Unclassified	1994-09-12
K941853	Passport	Boston Scientific Corporation	EZN	Class II	1994-09-12
K940736	Haig Nail	Howmedica Corp.	JDS	Class II	1994-09-12
K935279	Karl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz Hopkins II Rigid Autoclavable Telescope	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1994-09-12
K933108	Titan Trochantero-Diahyseal Total Hip Prosthesis	Landos, Inc.	LZO	Class II	1994-09-12
K922990	Hemodialysis Bath	Medi-Tech, Inc.	KPO	Class II	1994-09-12
K943757	Solder Aurolite Repair	Argen Precious Metals, Inc.	EJT	Class II	1994-09-09
K943755	Solder Aurolite Cb	Argen Precious Metals, Inc.	EJT	Class II	1994-09-09
K943738	Optibond-D	Sybron Dental Specialties, Inc.	KLE	Class II	1994-09-09
K943711	Ez-Screen:pcp	Editek, Inc.	LCM	Unclassified	1994-09-09
K943702	Avl 988-4 Electrolyte Analyzer	Avl Scientific Corp.	JFP	Class II	1994-09-09
K943620	Micro-Touch Latex Medical Gloves	Johnson & Johnson MEDICAL GmbH	LYY	Class I	1994-09-09
K943485	Monoject Horizontal Entry Sharps Container	Sherwood Medical Co.	FMI	Class II	1994-09-09
K943414	Propoxphene Eia Test	Diagnostic Reagents, Inc.	JXN	Class II	1994-09-09
K943182	Oral-B Perioflex Subgingival Irrigator	Oral-B Laboratories	EFS	Class I	1994-09-09
K942991	Qms Theophylline Cs	Seradyn, Inc.	LGS	Class II	1994-09-09
K942640	Dupont Dimension Amylase Method	Dupont Medical Products	JFJ	Class II	1994-09-09
K942632	Tnt Troponin T	Streck Laboratories, Inc.	JJX	Class I	1994-09-09
K942560	Magnetic Resonance Diagnostic Device	FUJIFILM Healthcare Americas Corporation	LNH	Class II	1994-09-09
K942552	Therapeutic Drug Monitoring Control, Unassayed	Medi-Tech, Inc.	DIF	Class I	1994-09-09
K942520	E-Vac-U-Accessories	Bull Frog Mfg. Co.	EIA	Class I	1994-09-09
K942098	Prospect Giardia	Alexon, Inc.	MHI	Class II	1994-09-09
K941346	Plasminogen Rid Test Kit	The Binding Site	DDX	Class I	1994-09-09
K941336	Combo Mask	Gam Industries, Inc.	KGB	Class I	1994-09-09
K940679	Rep Hdl/ldl-30 Kit - Cat. No. 3220,3221,3222	Helena Laboratories, Corp.	JHO	Class I	1994-09-09
K940594	Karl Storz Adult & Pediatric Nephroscope	Karl Storz Endoscopy-America, Inc.	FGA	Class II	1994-09-09
K940469	Urine Reagent Strip-3 Parameters	Teco Diagnostics	JIL	Class II	1994-09-09
K940162	Gonochek II Reagent Tubes	E-Y Laboratories, Inc.	JTO	Class I	1994-09-09
K940161	B-Lactamase Reagent Tubes	E-Y Laboratories, Inc.	JTO	Class I	1994-09-09
K936002	Cinemac Qas	Xre Corp.	IZI	Class II	1994-09-09
K935927	Concord/portex Epidural Catheters	Smiths Industries Medical Systems, Inc.	BSO	Class II	1994-09-09
K935896	Thixoflex	Zhermack Dental Production	ELW	Class II	1994-09-09