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 2166 of 3531

510(k) clearances, page 2166 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K934811	Pltl-1 & Pldl-1 510Nm Pulsed Dye Lasers	Candela Corporation	GEX	Class II	1994-09-01
K934711	Propaq ECG Telemetry Option	Protocol Systems, Inc.	DRG	Class II	1994-09-01
K934620	Ortholoc Advantim Fixed Stem Non-Porous Tibial Base	Wrightmedicaltechnologyinc	JWH	Class II	1994-09-01
K933519	Index Spo2 Simulator	Bio-Tek Instruments, Inc.	DQA	Class II	1994-09-01
K933290	Ortholoc Advantim	Wrightmedicaltechnologyinc	JWH	Class II	1994-09-01
K932918	Total Knee Kit	Biodynamic Technologies, Inc.	HWE	Class I	1994-09-01
K932017	Techmedica Continuum Hip with Ha Coating	Techmedica, Inc.	MEH	Class II	1994-09-01
K931155	Staple, Fixation Bone; Screw Fixation Bone	Roseburg SA	HWC	Class II	1994-09-01
K930275	Precision Osteolock Acetabular Component	Howmedica Corp.	JDI	Class II	1994-09-01
K930009	Stryker 2S Spinal System	Stryker Corp.	KWP	Class II	1994-09-01
K944027	Ag-839Pa CO2 Module and Accessories	Nihon Kohden America Inc	BXO	Class I	1994-08-31
K942939	Cordis Steadfast Magnetic Exchange System	Cordis US Corp.	DQO	Class II	1994-08-31
K942907	Jemsdal Mask	Respan Products, Inc.	BYG	Class I	1994-08-31
K942759	Opticon(tm) Connector Adapter II	Xintec Corporation	GEX	Class II	1994-08-31
K942333	Scimed En Tre' III Ptca Guide Wire	Scimed Life Systems, Inc.	DQX	Class II	1994-08-31
K930843	Rapid Disconnect Y-Set, Cat. No. 48-7000	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1994-08-31
K942436	Cedia Dau Barbiturate Assay	Microgenics Corporation	DIS	Class II	1994-08-30
K941937	Pikos E 01-B	BIOTRONIK AG	DXY	Class III	1994-08-30
K941001	Enzip Immunoturbidmetric Fibrinogen Assay Kit	Diagnostic Specialties	GIS	Class II	1994-08-30
K940697	Becton Dickinson Interlink(tm) Lever/y Lock	BD Becton Dickinson Vacutainer Systems Preanalytic	FPA	Class II	1994-08-30
K936224	Reusable Cannula Tracheostomy Tubes, Modified Heads	Mallinckrodt Medical Tpi, Inc.	JOH	Class II	1994-08-30
K935711	Bact/alert Fan Aerobic Culture Bottle	bioMerieux, Inc.	MDB	Class I	1994-08-30
K934501	Laser Photonics Ml755 Dermablaser	Laser Photonics, Inc.	GEX	Class II	1994-08-30
K934000	Sentry Aqueous Gel ECG Electrodes	Sentry Medical Products, Inc.	DRX	Class II	1994-08-30
K925560	Zsi Loop, Zsi Ball & Zsi Needle Electrodes	Zinnanti Surgical Instruments, Inc.	HGI	Class II	1994-08-30
K915229	Semen Analysis Kit	CooperSurgical, Inc.	POV	Class II	1994-08-30
K943912	Sunglasses	Kason Enterprises Limited	HQY	Class I	1994-08-29
K943818	Manual Laparosopic Handle, Interchangeable Laparoscopic Tool Units	R-Med, Inc.	GEI	Class II	1994-08-29
K943779	Argesol #720	Argen Precious Metals, Inc.	EJT	Class II	1994-08-29
K943677	Sunglasses	Jenn Wei Glass Company, Ltd.	HQY	Class I	1994-08-29
K943582	Softwear Porcelain System	Dentsply Intl.	EIH	Class II	1994-08-29
K943496	Monoject Tray Size Sharps Container	Sherwood Medical Co.	FMI	Class II	1994-08-29
K943469	Sonicator 730	Mettler Electronics Corp	IMG	Class II	1994-08-29
K943191	Microvasive(r) Monolith(tm) Mechanical Lithotriptor	Boston Scientific Corporation	LQC	Class II	1994-08-29
K942742	Alpha Bond-Rite Ii(tm) or Bond-Rite Ii(tm) 2-Paste Adhev	Wallace A. Erickson & Co.	DYH	Class II	1994-08-29
K941991	In-Room and Sharpstar	Sage Products LLC	MMK	Class II	1994-08-29
K941420	50 Degree Hri Prism Lens	Ocular Instruments, Inc.	HJK	Class II	1994-08-29
K940914	New Luting Cement Material (Nlc)	Dentsply Intl.	EMA	Class II	1994-08-29
K940908	Dunhall/omnii International Rotary Diamond Burs	Dunhall Pharmaceuticals, Inc.	DZP	Class I	1994-08-29
K935841	Dr Kool	Toronto Medical Corp.	ILO	Class II	1994-08-29
K933763	Save-T-Breath Ambilical Cord Clamp	Save-T-Breath Distributors C.C.	HFW	Class II	1994-08-29
K932046	Life-Tell T.s.s.	Raco Products Co.	DXH	Class II	1994-08-29
K931763	HF-Resection Electrode, Loop W/runner Endos/access	Olympus Corp.	FAS	Class II	1994-08-29
K931731	Storz M824 Fixation Device for Retractive Surgery	Storz Instrument Co.	HPL	Class I	1994-08-29
K930506	Therpac Radiotherapy Treatment Planning System	Pinecliff Assoc.	IYE	Class II	1994-08-29
K925606	Optical Zone/hexagonal/astigmatism/radial Markers	Chiron Vision Corp.	HMR	Class I	1994-08-29
K923889	O Butment Es Implant	O Co., Inc.	DZE	Class II	1994-08-29
K923529	Dms Data Management System/drs-4 Dialyzer Reproces	Seratronics, Inc.	LIF	Class II	1994-08-29
K920747	Pessary Flexible Silicone Donut Ring	Bioteque America Inc	HHW	Class II	1994-08-29
K943650	Liver Biopsy Kit	Argon Medical Devices, Inc	KNW	Class II	1994-08-26