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 2026-11-02, 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 1061 of 3531

510(k) clearances, page 1061 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K091489	Clearview Advanced Strep a , Model 737-430	Binax, Inc.	GTY	Class I	2009-09-04
K091434	Truly Automatic Arm Blood Pressure Monitordb21,db31,db22,db23,db71m,db32,db61m, Db62m, Db63m	Truly Instrument Limited	DXN	Class II	2009-09-04
K091415	Truly Automatic Wrist Blood Pressure Monitor, Model Dw100,dw200, Dw500,dw700,dw703,dw701m.702m	Truly Instrument Limited	DXN	Class II	2009-09-04
K091406	Atlas Spine Spacer	Atlas Spine, Inc.	MQP	Class II	2009-09-04
K091211	Ees Single Site Laparoscopic Seal Cap Assembly W/accessories, Model Ssl3p, Ees Fixed- Length Access Retractors	Ethicon Endo-Sugery, LLC	GCJ	Class II	2009-09-04
K090898	Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster Cs Catheter with Ez Steer	Biosense Webster Inc	DRF	Class II	2009-09-04
K090871	Cerament Ibone Void Filler High Contrast, Model a 0210-12	Bonesupport Inc	MQV	Class II	2009-09-04
K090254	Silver Impregnated Hydrofiber Dressing Reinforced with Nylon (Flat)	Convatec, A Division of E.R. Squibb & Sons	FRO	Unclassified	2009-09-04
K083559	Yuyue Oxygenmax Oxygen Concentrator, Models: 7F-5A/7f-5B	Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.	CAW	Class II	2009-09-04
K092412	Strong Implant Handpieces	Saeshin Precision Co., Ltd.	EFA	Class I	2009-09-03
K092373	Ics Chartr Ep 200	Natus Medical Denmark ApS	GWJ	Class II	2009-09-03
K092332	Jetstream G3 System, Model Pv31300 ( Jetstream G3 Catheter and Control Pod)., Pvcn100 (Pv Console)	Pathway Medical Technologies, Inc.	MCW	Class II	2009-09-03
K092324	Spiropro	Viasys Healthcare GmbH	DQA	Class II	2009-09-03
K091861	Vitros Chemistry Products Na + Dt Slides, Model 153 2290 and Dt Calibrator Kit, Model 195 7927	Ortho-Clinical Diagnostics, Inc.	JGS	Class II	2009-09-03
K091685	Kimguard One-Step Sterilization Wrap, Models Kc100, Kc200, Kc300, Kc400, Kc 500, Kc600	Kimberly-Clark Corporation	FRG	Class II	2009-09-03
K091635	Venus Diamond Flow	Kulzer GmbH	EBF	Class II	2009-09-03
K091632	Spk Sealant	3M Company	EBC	Class II	2009-09-03
K091537	Cynosure Smartlipo Multiwavelength Laser with 1440Nm Wavelength	Cynosure, LLC	GEX	Class II	2009-09-03
K091495	Single Use 3-Lumen Extraction Balloon V, Model V B-V233p-A,b-V233p-B,b-V433p-A,b-V433p-B, Bv243q-a, B-V243q-B, B-V443q-a	Olympus Medical Systems Corp.	LQR	Class II	2009-09-03
K091366	Insuflow Dewheart	Lexion Medical, LLC.	HIF	Class II	2009-09-03
K091155	Ascend	Neurometrix, Inc.	BXN	Class II	2009-09-03
K091066	Comfort Twin Nasal Mask	Respironics Inc., Sleep & Home Respiratory Group	BZD	Class II	2009-09-03
K090846	Gsp Instrument and Gsp Neonatal Htsh Kit	Revvity Health Sciences, Inc.	JLW	Class II	2009-09-03
K090760	Theratest El-Anti-Tpo and Theratest El-Anti-Thyroglobulin, Model 104-119, 103-120	Theratest Laboratories, Inc.	JZO	Class II	2009-09-03
K090315	Staxx Xd System	Spine Wave Inc	MQP	Class II	2009-09-03
K083602	Kappa Light Chains	Sentinel CH SpA	DFH	Class II	2009-09-03
K083288	Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV Blocker	Innova Vision Inc.	LPL	Class II	2009-09-03
K082939	Cook Fetal Membrane Manipulator, Model -Fmm-122400	Cook Incorporated	KNA	Class II	2009-09-03
K092470	Optical Coherence Tomography 3D Oct-2000	Topcon Corp.	OBO	Class II	2009-09-02
K091974	Modification to Cd Horizon Spinal System	Medtronic Sofamor Danek USA Inc	NKB	Class II	2009-09-02
K091877	Chison Digital Color Doppler Ultrasound System, Convex Probe, Linear Probe, Phased Array Probe, Transvaginal	Chison Medical Imaging Co., Ltd.	ITX	Class II	2009-09-02
K091841	Bridgepoint Medical Crossboss Catheter, Model M-2000	Boston Scientific Corporation	DQY	Class II	2009-09-02
K091798	Merete Compression Screws	Merete GmbH	HWC	Class II	2009-09-02
K091718	Neutrasal	Bartor Pharmacal Co., Inc.	LFD	Unclassified	2009-09-02
K091359	Gso Pct Spinal System	Gold Standard Orthopaedics, LLC	KWP	Class II	2009-09-02
K091312	Ps Medical Strata Nsc Lumboperitoneal Valve and Shunt System	Medtronic Neurosurgery	JXG	Class II	2009-09-02
K091166	Imrx	Imris, Inc.	LNH	Class II	2009-09-02
K083724	Wiener Lab. Urine Strip 10 and 11	Wiener Laboratorios S.A.I.C.	JIO	Class II	2009-09-02
K092419	Axsos Locked Plating System Line Extension of 3Mm Locking Inserts	Howmedica Osteonics Corp	HRS	Class II	2009-09-01
K092393	Ek/p. Aeruginosa Pna Fish	Advandx, Inc.	JSS	Class I	2009-09-01
K092284	Lipisystems Aquavage, Models Av2000 and Av1200	Medical Device Resource Corp.	MUU	Class II	2009-09-01
K091869	Sils Clincher, Sils Dissector, Sils Grasper, Sils L-Hook, Sils Shears	Covidien Lp, Formerly Registered AS United States	GCJ	Class II	2009-09-01
K091676	Mc-245, Mc-246, Mc-247, Mc-341, Mc-343, Mc-344	Omron Healthcare Co., Ltd.	FLL	Class II	2009-09-01
K090496	Qwiklead Reusable Electrocardiograph Electrode Patch	Cardiac Lead Technologies, Inc.	DRX	Class II	2009-09-01
K090394	Valved Tearway Introducer	Medcomp	DYB	Class II	2009-09-01
K090156	Isolyser Sharps Room System, Model 800; Isolyser Sharps Management System, Models 2400, 4000, 10000	WCM Waste & Compliance Management, Inc.	FMI	Class II	2009-09-01
K083846	Xtag Cystic Fibrosis 39 Kit V2, (Cftr 39 Kit V2), Model I027c0231, I027d0266, I027e0267	Luminex Molecular Diagnostics Inc	NUA	Class II	2009-09-01
K083744	Binaxnow Malaria Positive Control Kit, Model 665-010	Binax, Inc.	MJZ	Class I	2009-09-01
K083665	Verify Scbi 275F 3-10	STERIS Corporation	FRC	Class II	2009-09-01
K083428	F7244, F7255, F7266, F7277, F7288, F7233, F7234 Series of Battery-Powered Cautery	Fiab SpA	HQP	Class II	2009-09-01