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 2161 of 3531

510(k) clearances, page 2161 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K943171	Crossfire(tm) (705-10650)	Cardiogenes	GEX	Class II	1994-09-20
K942809	Acetabular Dome Hole Plugs	Osteonics Corp.	JDL	Class III	1994-09-20
K942619	Emit 2000 Digoxin Assay/calibrators	Syva Co.	LFM	Class II	1994-09-20
K942479	Integral Co-Cr Femoral Component	Zimmer GmbH	JDG	Class II	1994-09-20
K942464	Uc Qik 1-Step Hcg Test	Eucardio Laboratory, Inc.	JHI	Class II	1994-09-20
K942369	Gamma-Bct Intact Pth	Immunodiagnostic Systems Ltd.	CEW	Class II	1994-09-20
K942060	P.f.c. Cement Restrictor	Johnson & Johnson Professionals, Inc.	LZN	Class II	1994-09-20
K942059	Kt2000 Knee Ligament Arthrometer	Medmetric Corp.	LYH	Class I	1994-09-20
K941546	Somatom Project 059	Siemens Corp.	JAK	Class II	1994-09-20
K941486	Integrity Total Hip System, Non-Porous	Kirschner Medical Corp.	JDI	Class II	1994-09-20
K940983	The Karl Storz Uromat(tm)	Karl Storz Endoscopy-America, Inc.	LJH	Class II	1994-09-20
K940426	Medtronic Hemotec Act II Automated Coagulation Timer	Medtronic Hemotec, Inc.	GKN	Class II	1994-09-20
K940403	Elias Cardiolipin Antibodies	Elias U.S.A., Inc.	MID	Class II	1994-09-20
K940395	Wallstent Esophageal Prosthesis	Boston Scientific Corporation	ESW	Class II	1994-09-20
K935443	Add Line Devices(parts) Electric Handpiece Systems	Osada Electric Co., Ltd.	DZH	Class II	1994-09-20
K935393	Chlamydia Microplate Eia, Chlamydia Microplae Eia Blocking Assay	Bio-Rad Laboratories Inc.	LJC	Class I	1994-09-20
K934965	Binax Legionella Urinary Antigen Eia	Binax, Inc.	MJH	Class II	1994-09-20
K934550	Immunocard Mycoplasma	Meridian Diagnostics, Inc.	LJZ	Class I	1994-09-20
K934493	Prospect Microplate Assay	Alexon, Inc.	LLH	Class I	1994-09-20
K932595	Orthosorb(tm) Absorbable Cement Restrictor	Johnson & Johnson Orthopaedics, Inc.	LZN	Class II	1994-09-20
K943372	Calcium Hydroxide Paste	Ultradent Products Inc.	EJK	Class II	1994-09-19
K943276	Warmtouch Plastic Warming Cover	Mallinckrodt Medical	DWJ	Class II	1994-09-19
K943022	Cardiometrics Flowire Doppler Guide Wire	Cardio Metrics, Inc.	DQX	Class II	1994-09-19
K942920	Medair Excel 2000	Medifloat, Inc.	FNM	Class II	1994-09-19
K942919	Mercury Expiratory Resistance Exerciser	Mercury Ent., Inc. D/B/A Mercury Medical	BWF	Class II	1994-09-19
K942903	Sharps-Tainer Small Opening	Winfield Co., Inc.	FMI	Class II	1994-09-19
K942901	Sharps-Tainer Large Opening	Winfield Co., Inc.	FMI	Class II	1994-09-19
K942028	Rx90 Femoral Component	Zimmer GmbH	JDG	Class II	1994-09-19
K942027	Impact Co-Cr 1-Piece Femoral Component	Zimmer GmbH	JDG	Class II	1994-09-19
K941444	Bhi Agar with Vancomycin	Remel Inc	JSO	Class II	1994-09-19
K941443	Synergy Quad	Remel Inc	JSO	Class II	1994-09-19
K941174	Pioneer Laboratories Cable Pin	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	HWC	Class II	1994-09-19
K940593	Disposable Microstaar Injector	Staar Sugical	KYB	Class I	1994-09-19
K935975	Remel Piperacillin/tazobactam 100/10 Mcg	Remel Inc	JTN	Class II	1994-09-19
K935384	Examination Gloves, Powder Free	Jf Trading Co., Ltd.	LYY	Class I	1994-09-19
K935254	Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma	Sekisui Diagnostics, LLC	GIZ	Class II	1994-09-19
K932550	Powder Free Examination Gloves	Unigloves, Ltd.	LYY	Class I	1994-09-19
K932411	Vital-Port Vasc Access Sys W/dual Lum Injectrol Ca	Med Institute, Inc.	LJT	Class II	1994-09-19
K925555	Steri-Oss Threaded Tps Hex Series Implant	Steri-Oss, Inc.	DZE	Class II	1994-09-19
K925481	Steri-Oss Titanium Plasma Spray Series Implant	Steri-Oss, Inc.	DZE	Class II	1994-09-19
K944150	Micro X-65 HF	Fischer Imaging Corp.	IZO	Class I	1994-09-16
K944149	Micro X-80 HF	Fischer Imaging Corp.	IZO	Class I	1994-09-16
K944148	Micro X-30Hf	Fischer Imaging Corp.	IZO	Class I	1994-09-16
K944147	Micro X-50 HF	Fischer Imaging Corp.	IZO	Class I	1994-09-16
K943927	End-O-Fog Endoscopic Fog Elimination System	American Hydro-Surgical Instruments, Inc.	GCJ	Class II	1994-09-16
K943848	Collar Button Venturi Vent Tube	Micromed Development Corp.	ETD	Class II	1994-09-16
K943841	Sophos Dental Diamond	Sophos Technologic	DZP	Class I	1994-09-16
K943735	Proshield Plus Multiple Gloves	Sino (U.S.A.) Co.	LYY	Class I	1994-09-16
K943718	Epistat-II Nasal Catheter	Merocel Corp.	EMX	Class I	1994-09-16
K943399	The Ss-99	Instantron	KCW	Class I	1994-09-16