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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3027 of 3529

510(k) clearances, page 3027 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K844140	Stockert-Shiley Atrial Left Ventricular Vent Cath	Shiley, Inc.	DWF	Class II	1984-12-27
K844139	Stockert-Shiley Intracardiac Suckers	Shiley, Inc.	DWF	Class II	1984-12-27
K844138	Stockert-Shiley Handheld Remote Control Intracardi	Shiley, Inc.	DWF	Class II	1984-12-27
K844137	Stockert-Shiley Venous Catheter & Aortic Arch Cann	Shiley, Inc.	DWF	Class II	1984-12-27
K844100	Canmed 101	Medtronic, Inc.	DRX	Class II	1984-12-27
K844099	Canmed 102	Medtronic, Inc.	DRX	Class II	1984-12-27
K844035	Menstrual Pads	American Disposable Products Corp.	HHD	Class I	1984-12-27
K844003	Elecath Ventricular Pacing Wedge Pressure Cath	Electro-Catheter Corp.	LDF	Class II	1984-12-27
K843983	Myocardial Insulator	Norton Texas Medical Products	DTR	Class II	1984-12-27
K843860	Oxyscreen	Erich Jaeger, Inc.	BZC	Class II	1984-12-27
K843841	Ergo-Oxyscreen	Erich Jaeger, Inc.	BZG	Class II	1984-12-27
K843802	Stockert-Shiley Universal Level Sensor	Shiley, Inc.	DTW	Class II	1984-12-27
K843798	Meadox Surgimed a/s Catheter Sheath Sys	Meadox Surgimed, Inc.	DYB	Class II	1984-12-27
K843706	Medtronic 6957	Medtronic, Inc.	DTB	Class III	1984-12-27
K843398	Osteogen	Impladent, Ltd.	LYC	Class II	1984-12-27
K843376	ECG Patient Monitor	Rigel Medical Electronics, Inc.	DRT	Class II	1984-12-27
K843320	Rt-50	General Electric Co.	IYO	Class II	1984-12-27
K842373	Venous Reservoir-Bmr-1500-Hard Shell	American Bentley	DTP	Class II	1984-12-27
K842218	Anti-Leu-4 Fitc Lysin C Buffer	BD Becton Dickinson Vacutainer Systems Preanalytic	LIZ	Class II	1984-12-27
K840417	Ebna Acif Kit	Litton Bionetics	LLM	Class I	1984-12-27
K811259	Cordis Encor Atrial Lead	Cordis US Corp.	DTB	Class III	1984-12-27
K844903	Mic-Bio-Plate	Pasco Laboratories, Inc.	JWY	Class II	1984-12-24
K844761	Schwartz/norris Corneal Light Shield	Medical Instrument Development Laboratories, Inc.	HOY	Class I	1984-12-24
K844496	Medipart Xenon Breathing Kit Mp-01Xm	Medipart Jerry Alexander	IYT	Class II	1984-12-24
K844312	Me-Too Oxygen Concentrator	Medequip Co.	CAW	Class II	1984-12-24
K844223	Premier O2 Oxygen Concentrator	Everest & Jennings, Inc.	CAW	Class II	1984-12-24
K844198	Argon Laser Photocoagulator Sys Repeat Mode	Nidek, Inc.	HQB	Class II	1984-12-24
K844197	Argon/krypton & Krypton Laser Photocoagulation Sys	Nidek, Inc.	HQB	Class II	1984-12-24
K843486	Vibrameter	Somedic AB	LLN	Class I	1984-12-24
K844351	Opti-Lite	Innovators, Inc.	EBZ	Class II	1984-12-21
K843550	Orthomag Magnetic Force System	Medical Magnetics, Inc.	ECO	Class I	1984-12-21
K844273	Autoranging Digital Thermometer	Micro Idea Instrument Co., Ltd.	FLL	Class II	1984-12-20
K843165	Ultrasound 72X & Annular Array Scan-	Advanced Technology Laboratories, Inc.	JOP	Class II	1984-12-20
K843131	Access & 72X Ultrasound Scanhead Um4	Advanced Technology Laboratories, Inc.	JOP	Class II	1984-12-20
K842559	Whiteside Ortholoc Total Hip Femoral	Dow Corning Corp. Healthcare Industries Materials	KWL	Class II	1984-12-20
K844614	IV Start Kit	Packaging Technologies, Inc.	LRS	Class II	1984-12-19
K844611	Single Basin Set	Packaging Technologies, Inc.	FRG	Class II	1984-12-19
K844255	Gent-L-Kare Sterile i.v. Start Kit	Geneva Laboratories, Inc.	FPA	Class II	1984-12-19
K844054	Canon Auto Keratometer K-1	Canon Medical Components U.S.A., Inc.	HLI	Class II	1984-12-19
K844053	Canon 60 Degree Fundus Camera Cf-60S	Canon Medical Components U.S.A., Inc.	HFI	Class II	1984-12-19
K843885	Percutaneous Aspiration Biopsy Tray	Applied Medical Devices, Inc.			1984-12-19
K843783	Wet Pack	E.M. Adams Co., Inc.	EFQ	Unclassified	1984-12-19
K843391	Infusion Aspiration Vitrectomy Sys	Medical Instrument Development Laboratories, Inc.	HQE	Class II	1984-12-19
K842793	Mvs XII	Medical Instrument Development Laboratories, Inc.	HQE	Class II	1984-12-19
K842339	Compustress Stress Testing Sys	Intl. Medical, Inc.	DQK	Class II	1984-12-19
K844796	Micro-Beta U100 Syringe	Orange Medical Instruments, Inc.	FMF	Class II	1984-12-18
K844078	Provider Pa 3000 Infusion System	Pancretec, Inc.	FRN	Class II	1984-12-18
K843978	Enaii Test Kit(ss-A(ro) & Ss-B(la) Autoantibody	Behring Diagnostics, Inc.	LLL	Class II	1984-12-18
K843760	Uropaper Eiken G	Syn-Kit, Inc.	JIL	Class II	1984-12-18
K843759	Uropaper Eiken Hag	Syn-Kit, Inc.	JIL	Class II	1984-12-18