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 1818 of 3531

510(k) clearances, page 1818 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K981279	Tibc	Abbott Medical	JMO	Class I	1998-05-20
K981245	Alkaline Phosphatase (Alkp)	Abbott Medical	CJE	Class II	1998-05-20
K981188	Electrosurgical Cautery Probes	Microline Pentax, Inc.	GEI	Class II	1998-05-20
K981156	Dyonics Intelijet Inflow/outflow Cannula	Smith & Nephew, Inc.	HRX	Class II	1998-05-20
K981070	20-Hole Adaptation Plate	Zimmer GmbH	JEY	Class II	1998-05-20
K981045	Exmoor Teflon Loop Replacement Prosthesis	Exmoor Plastics Limited	ETB	Class II	1998-05-20
K980981	Omega Ha Coated Total Hip System	Osteoimplant Technology, Inc.	LPH	Class II	1998-05-20
K980880	Sensi-Derm Latex Surgical Gloves (Powdered)	Ansell Perry	KGO	Class I	1998-05-20
K980866	Medi-Dx 7000 Cpt with Amrex Electrodes	Neuro-Diagnostic Assoc.	GWF	Class II	1998-05-20
K980862	Titanium Spinal Rod System	United States Surgical, A Division of Tyco Healthc	MNH	Class II	1998-05-20
K980861	Dumex Pak-Its Cotton Gauze Packing Impregnated with Hydrogel	Dumex Medical Surgical Products, Ltd.	MGQ	Unclassified	1998-05-20
K980842	Copper Tongue Scraper	Ontel Products Corporation	LCN	Class I	1998-05-20
K980841	Rci Fixation Screws	Smith & Nephew, Inc.	HWC	Class II	1998-05-20
K980837	Shimadzu Whole Body X-Ray Computed Tomography Scanner Sct-7000Ts	Shimadzu Medical Systems	JAK	Class II	1998-05-20
K980794	Dual Lock Hip Stem	Depuy, Inc.	JDI	Class II	1998-05-20
K980750	Radiocameras Patient Positioning System	Surgical Navigation Technologies, Inc.	IYE	Class II	1998-05-20
K980685	Modified Versapulse Select Ho:yag and Ho:yag/nd:yag Lasers	Lumenis Ltd	GEX	Class II	1998-05-20
K980665	Repicci II Unicondylar Knee All Poly Tibial Components	Zimmer GmbH	HRY	Class II	1998-05-20
K980636	Fiber Optic Endoillumination Probe	Dutch Ophthalmic USA, Inc.	FFS	Class II	1998-05-20
K980563	Skar-Kare Sheet	Life Medical Sciences, Inc.	MDA	Class I	1998-05-20
K980319	Durex Ultra Comfort	London Intl., LLC	HIS	Class II	1998-05-20
K980125	Reference Population for Norland Apollo X-Ray Bone Densitometer	Norland Corp.	KGI	Class II	1998-05-20
K974830	Ultra Bili Light	Physician Engineered Products, Inc.	LBI	Class II	1998-05-20
K974540	Sis Hernia Repair Device	Sentron Medical, Inc.	FTL	Class II	1998-05-20
K974536	Photoderm Hr System	Esc Medical Systems, Ltd.	GEX	Class II	1998-05-20
K974513	Pinpoint	Philips North America LLC	JAK	Class II	1998-05-20
K973615	Skingard Tpf/aosstex Tpf/sensifree/essential Tpf/ameriglo Tpf Latex Examination Gloves	Macro Rubber Industrial, Inc.	LYY	Class I	1998-05-20
K972595	Aldrete Epidural Needle without Introducer	Avid N.I.T., Inc.	BSP	Class II	1998-05-20
K981169	Rondex CPR ISO-Shield	Rondex Products, Inc.	CBP	Class II	1998-05-19
K981116	Sovereign Cataract Extraction System	Allergan	KYG	Class I	1998-05-19
K980797	Peregrine Fiber Optic Multi-Function Manipulator	Peregrine Surgical, LLC.	MPA	Class II	1998-05-19
K980658	Psn Dialyzer, Model Psn 130/R5m4233, Model Psn-150/R5m4234	Baxter Healthcare Corporation	FJI	Class II	1998-05-19
K980656	Psn Dialyzer, Model Psn-170/R5m4235, Psn-210/R5m236	Baxter Healthcare Corporation	KDI	Class II	1998-05-19
K980625	Siemens Multiview Workstation Enhanced with Diagnostic Statements (Rest ECG)	Siemens Medical Solutions USA, Inc.	DSI	Class II	1998-05-19
K980604	Smith & Nephew Dyonics Endoscopes and Accessories	Smith & Nephew, Inc.	GCJ	Class II	1998-05-19
K980295	Ophthavision Imaging System	Mrp Group, Inc.	HKI	Class II	1998-05-19
K980292	Cataract Liquefracture Device	Alcon Laboratories	MUS	Class II	1998-05-19
K980018	Cristobal	Newave Medical, Inc.	EBF	Class II	1998-05-19
K981401	Boehringer Mannheim Precinorm Precipath Protein Controls	Boehringer Mannheim Corp.	JJY	Class I	1998-05-18
K981349	Smart-Feel Powder Free Nitrile Examination Gloves	Smart Glove Corp. Sdn Bhd	LZA	Class I	1998-05-18
K981348	Smarttex Prepowdered Latex Examination Gloves	Smart Glove Corp. Sdn Bhd	LYY	Class I	1998-05-18
K981347	Smarttex Powder Free Latex Examination Gloves, with Protein Labeling Claim	Smart Glove Corp. Sdn Bhd	LYY	Class I	1998-05-18
K981338	Ld-1	Abbott Medical	JGF	Class II	1998-05-18
K981232	Ca	Abbott Mfg., Inc.	CJY	Class II	1998-05-18
K981085	Gambro Hemodialysis Water Treatment System	Gambro Healthcare	FIP	Class II	1998-05-18
K981020	Zeus Anti-Cardiolipin Igs Elisa Test System	Zeus Scientific LLC	MID	Class II	1998-05-18
K981002	Orion Wx Dental Alloy	European Dental Imports, Inc.	EJS	Class II	1998-05-18
K981001	Orion Vesta Dental Alloy	European Dental Imports, Inc.	EJS	Class II	1998-05-18
K980955	Pasco Mic and Mic/id Panels	Pasco Laboratories, Inc.	JTN	Class II	1998-05-18
K980773	Etest Grepafloxacin	Ab Biodisk	JWY	Class II	1998-05-18