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 2123 of 3531

510(k) clearances, page 2123 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K940919	Chief Sr	Redman, Inc.	IPL	Class II	1995-02-03
K940852	Chief Standup Wheelchair	Redman, Inc.	IPL	Class II	1995-02-03
K940851	Red Pack Manlual Power Wheelchair Conversion Kit	Redman, Inc.	ITI	Class II	1995-02-03
K940657	IV Bag Pump	Halyard Health	FPA	Class II	1995-02-03
K936108	Masterscreen Body	Erich Jaeger GmbH & Co. KG	JEH	Class II	1995-02-03
K935751	Geronimo Pr	Redman, Inc.	ITI	Class II	1995-02-03
K935750	Geronimo	Redman, Inc.	ITI	Class II	1995-02-03
K930458	Multi-Dop L	Dantec Medical, Inc.	IYN	Class II	1995-02-03
K925964	Image Transport Series III	Dataview Imaging Intl., Inc.	LMD	Class I	1995-02-03
K925963	Image Transport Series II	Dataview Imaging Intl., Inc.	LLZ	Class II	1995-02-03
K950203	Protemp(r) Garant	Espe GmbH & Co. KG.	EBG	Class II	1995-02-02
K946025	3M X-Large Sheet #7979/ #7979Ns	3M Healthcare	KKX	Class II	1995-02-02
K945711	Excel-P Formula Auto-Cure Denture Base	St. George Technology, Inc.	EBI	Class II	1995-02-02
K945569	Gcii Agar with Isovitalx(r) Enrichment	Becton Dickinson Microbiology Systems	JSO	Class II	1995-02-02
K945366	Parapost Cement	Coltene /Whaledent AG	EMA	Class II	1995-02-02
K945032	Voyager 522	Madsen Electronics, Inc.	EWO	Class II	1995-02-02
K944670	Jarit Recommended Sinus Instruments	J. Jamner Surgical Instruments, Inc.	EOB	Class II	1995-02-02
K944068	Restore Self Tapping Dental Implant Syst (5, 5.5,6Mm)	Lifecore Biomedical LLC	DZE	Class II	1995-02-02
K943393	Civco Probe Boot/cord Cover	CIVCO Medical Instruments Co., Inc.	KKX	Class II	1995-02-02
K942669	Smt-50Cx/h	Shimadzu Medical Systems	LNH	Class II	1995-02-02
K941941	Bone Mulch Screw	Zimmer GmbH	HWC	Class II	1995-02-02
K950278	Mini Laparoscopy for General Surgery	OLYMPUS Corporation of the Americas	GCJ	Class II	1995-02-01
K950249	Vasotrac Blood Pressure Monitor, Model - Apm 205	Medwave, Inc.	DXN	Class II	1995-02-01
K950231	Laparoscope and Accessories for General Surgery	OLYMPUS Corporation of the Americas	GCJ	Class II	1995-02-01
K950170	Conmed Soft-Tip Suction/irrigation Cannulae	Conmedcorp	GCJ	Class II	1995-02-01
K946110	Regain Stand-Up Wheelchair	Regain, Inc.	IPL	Class II	1995-02-01
K946079	Cad on Wheels	Rehab 'N Motion Technologies	IOR	Class I	1995-02-01
K945921	Echo Star Needle Set	Ideamatrix	FCG	Class II	1995-02-01
K945635	Trans X-1000	Canon Medical Components U.S.A., Inc.	KPX	Class II	1995-02-01
K945528	Sunglasses and Sport Sunglasses	Lily & Assoicates, Inc.	HQY	Class I	1995-02-01
K945491	Serim(tm) Bicarb Ph Reagent Strips	Serim Research Corp.	MNV	Class II	1995-02-01
K945464	Fukuda Denshi Mode Hg-302 Pulse Oximeter Module	Fukuda Denshi USA, Inc.	DQA	Class II	1995-02-01
K945317	Nezhat-Dorsey (Tm) Electroshield(tm) Probes and Accessories	American Hydro-Surgical Instruments, Inc.	GEI	Class II	1995-02-01
K945245	Blood Kit, Sexual Assault Kit	Lynn Peavey Co.	JKA	Class II	1995-02-01
K945233	Pediatric Osteotomy System	Howmedica Corp.	KTT	Class II	1995-02-01
K945027	Trochanter Mesh	Acu Med, Inc.	EZX	Class II	1995-02-01
K944946	Consenus Hip System Femoral Canal Starter Reamer	U.S. Medical Products, Inc.	HWE	Class I	1995-02-01
K944831	Innovasive 1.9Mm, 2.8Mm, 3.5Mm, 4.5Mm Roc Suture Bone Fastener	Innovasive Devices, Inc.	MBI	Class II	1995-02-01
K944812	Clinical Blood Gas Mixture	Laboratory & Specialty Gases, Inc.	BXK	Class I	1995-02-01
K943492	Arthrex Staples	Arthrex GmbH	JDR	Class II	1995-02-01
K943464	Philips Improved Check Radiograph Option	Philips North America LLC	IYE	Class II	1995-02-01
K943426	Arthroscope,rigid Rod-Lens Diagnostic Endoscope	Schoelly Technologies, Inc.	HRX	Class II	1995-02-01
K943113	Ssd-2000 Diagnostic Ultrasound System	Aloka Co., Ltd.	IYO	Class II	1995-02-01
K942848	Strato Medical Lifeport Lps 7515	Strato Medical Corp.	LJT	Class II	1995-02-01
K942117	Sta Automated Multi-Parametric Analyzer	American Bioproducts Co.	GKP	Class II	1995-02-01
K942019	Model Fp-100	International Medical Designs, Inc.	JAA	Class II	1995-02-01
K941769	Knee Prothesis	Joint Medical Products Corp.	JWH	Class II	1995-02-01
K940859	Pacspro I	Advanced Video Products, Inc.	LMD	Class I	1995-02-01
K940555	Sandoz Nutrition Compat Enteral Feed Pump W/hydration	Sandoz Nutrition	LZH	Class II	1995-02-01
K935255	Eldor Needle	Csen, Ltd.	BSP	Class II	1995-02-01