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 1452 of 3531

510(k) clearances, page 1452 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K031828	Naturalase Lp Nd:yag Laser	Focus Medical, LLC.	GEN	Class I	2003-07-17
K031817	Cellplex Tcp Synthetic Cancellous Bone	Wrightmedicaltechnologyinc	MQV	Class II	2003-07-17
K031767	Mentor Obtape Trans-Obturator Tape	Mentor	OTN	Class II	2003-07-17
K031650	Ferritin Generation 2	Roche Diagnostics GmbH	DBF	Class II	2003-07-17
K031565	Xpect Influenza A/b	Remel Inc	PSZ	Class II	2003-07-17
K031467	Glasionomer Fx-II	Shofu Dental Corp.	EMA	Class II	2003-07-17
K031438	Acumed Small Bone Locking Rod System II	Acumed LLC	HSB	Class II	2003-07-17
K031319	Osteo-G Bone Void Filler System	Aspine USA, Inc.	MQV	Class II	2003-07-17
K031247	Cardioblate Bipolar Radiofrequency Surgical Ablation System	Medtronic, Inc.	GEI	Class II	2003-07-17
K031227	Lordex Power Traction Equipment	Ever Prosperous Instrument, Inc.	ITH	Class II	2003-07-17
K031216	Monoplus Poly-P-Dioxanone Monofilament Absorbable Surgical Suture	Aesculap Inc	NEW	Class II	2003-07-17
K031211	Attain Prevail Steerable Catheter Set, Model 6228Cth	Medtronic, Inc.	DQY	Class II	2003-07-17
K031179	Taga Velocity Humidifier	Taga Medical Technologies, Inc.	BTT	Class II	2003-07-17
K030692	Power Laser 90	Andi Electromedical ApS	NHN	Class II	2003-07-17
K030426	Omnilux Red	Photo Therapeutics Limited	GEX	Class II	2003-07-17
K030403	Cefar Rehab 2 and Rehab 2 Pro	Cefar Medical AB	IPF	Class II	2003-07-17
K030342	Lumenis Family of Ipl Systems and Combination Ipl/nd:yag Systems	Lumenis Ltd	GEX	Class II	2003-07-17
K030288	Polygraft Bone Graft Substitute	Osteobiologics, Inc.	MQV	Class II	2003-07-17
K030158	Unit, Cautery, Tehrmal,battery-Powered	Walsh Medical Devices, Inc.	GEI	Class II	2003-07-17
K030087	Spinal Concepts, Inc. Bacfix Ti Spinal System	Spinal Concepts, Inc.	NKB	Class II	2003-07-17
K024228	Rx300 Oxygen Analyzer	Teledyne Analytical Instruments	CCL	Class II	2003-07-17
K024155	Mx 300 Oxygen Monitor	Teledyne Analytical Instruments	CCL	Class II	2003-07-17
K021841	Comppac Ventilator Models 200 & Ps11 Power Supply/charger	Pneupac, Ltd.	BTL	Class II	2003-07-17
K020478	Electromedicarin 900	Electromedicarin, S.A.	IPF	Class II	2003-07-17
K032092	Olympus Xcyf-Tp3 Cystofiberscope/nephrofiberscope	Olympus Optical Co., Ltd.	FCL	Class I	2003-07-16
K031890	Mas Bilirubin Liquid Assayed Bilirubin Control	Medical Analysis Systems, Inc.	JJX	Class I	2003-07-16
K031880	Ammonia/ethanol/co2 Calibrator, Control Normal, Control Abnormal	Roche Diagnostics GmbH	JIX	Class II	2003-07-16
K031679	Bd Phonenix Automated Microbiology System	Becton Dickinson & Co	LON	Class II	2003-07-16
K031545	Sensititre 18-24 Hour Susceptibility Plate	Trek Diagnostic Systems, Ltd.	JWY	Class II	2003-07-16
K031490	Rubellacol	Immunostics, Inc.	LQN	Class II	2003-07-16
K031376	Dinamap Pro 1000 V3 Monitor, Model 1100 Series	GE Medical Systems Information Technologies, Inc.	MHX	Class II	2003-07-16
K031352	Bio-Logic Insert Earphones	Bio-Logic Systems Corp.	EWO	Class II	2003-07-16
K030960	Ecn Electronic Video Cystonephroscope	Acmi Corporation	FAJ	Class II	2003-07-16
K031870	Synchron Systems Valproic Acid (V-Pa) Reagent	Siemens Healthcare Diagnostics Inc.	LEG	Class II	2003-07-15
K031844	Vaxcel with Pasv Port (Low Profile), Models 45-236 and 45-238	Boston Scientific Corporation	LJT	Class II	2003-07-15
K031416	Clearmedical/critikon Blood Pressure Cuff; Clearmedical/welch Allyn Blood Pressure Cuff	Clearmedical, Inc.	DXQ	Class II	2003-07-15
K031400	Fabius Tiro Anesthesia System	Draeger, Inc.	BSZ	Class II	2003-07-15
K031273	Ameritek Sure-Point Hdr Needle Template	Amertek Medical, Inc.	JAQ	Class II	2003-07-15
K031250	Dbc Press Acupuncture Needles	Lhasa Medical, Inc.	MQX	Class II	2003-07-15
K031207	Safety Release Arch Bar Kit	Casey Surgical, LLC	DYX	Class II	2003-07-15
K031201	Ortho Development Balanced Knee Modular Tibial System	Ortho Development Corp.	JWH	Class II	2003-07-15
K031145	Estylus Electric Motor System	Dentsply Intl.	EFB	Class I	2003-07-15
K031119	Mayo Clinic Bc-10 1.5T	Mayo Medical Ventures	MOS	Class II	2003-07-15
K031044	Atac Pak Uric Acid Reagent and Atac Calibrator	Clinical Data, Inc.	KNK	Class I	2003-07-15
K031016	Freelite Human Kappa and Lambda Free Kits for Use on the Dad Behring Nephelometer II	The Binding Site	DEH	Class II	2003-07-15
K030939	Philips Compurecord Peri-Operative Information System Software	Philips North America LLC	BSZ	Class II	2003-07-15
K030830	B. Braun Nerve Block Catheter	B.Braun Medical, Inc.	MEB	Class II	2003-07-15
K030135	Safety Introducer Needle	B.Braun Medical, Inc.	DYB	Class II	2003-07-15
K032008	Vaxcel with Pasv Port, Model 45-213	Boston Scientific Corporation	LJT	Class II	2003-07-14
K031784	Acon Strep a Rapid Test Device	Acon Laboratories, Inc.	GTY	Class I	2003-07-14