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 1870 of 3531

510(k) clearances, page 1870 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K972282	Spacelabs Medical Pcis Patient Monitors	GE Healthcare	DSI	Class II	1997-09-25
K972265	A1c 2.2 Plus - Automated Glycohemoglobin Analyzer	Tosoh Medics, Inc.	LCP	Class II	1997-09-25
K972199	Signal-Averaged High Resolution P Wave Analysis	Marquette Electronics, Inc.	DPS	Class II	1997-09-25
K971821	Unica 315 M CO2 Surgical Laser System	Reliant Technologies, Inc.	GEX	Class II	1997-09-25
K971267	Shiley Extended Length, Disposable Cannula, Tracheostomy Tube: Cuffed, Distal Extension, Cuffed, Proximal Extension, Cuf	Mallinckrodt Medical	JOH	Class II	1997-09-25
K970061	Accutorr Plus Non Invasive Blood Pressure Monitor (0998-00-0117-Xx)	Datascope Corp.	DQA	Class II	1997-09-25
K964406	Automated Multi-Point Blood Volume Analyzer	Daxor Corporation	JWO	Class II	1997-09-25
K961751	W.m.e. Gps 1001	Weaver Medical Electronics, Inc.	IPF	Class II	1997-09-25
K955497	Gambro Fh 22H Fiber Hemofltr/prisma Fh 22H Blood Tubing/hemofltr Set	Cobe Renal Care, Inc.	KDL	Class II	1997-09-25
K973339	Disetronic Penfine Injection Pen Needle	Disetronic Medical Systems	FMI	Class II	1997-09-24
K973035	Viola II Dental Camera System	Innovative Medical Systems, Inc.	EIA	Class I	1997-09-24
K972985	Splint It	Jeneric/Pentron, Inc.	ELS	Class II	1997-09-24
K972853	Cholesterol Rapid Liquid Reagent	Reagents Applications, Inc.	CHH	Class I	1997-09-24
K972379	Precisa N	Rudolf Riester GmbH & Co. KG	DXQ	Class II	1997-09-24
K972378	Sanaphon N	Rudolf Riester GmbH & Co. KG	DXQ	Class II	1997-09-24
K972377	Ri-Mega	Rudolf Riester GmbH & Co. KG	DXQ	Class II	1997-09-24
K971601	Olympic Bili-Bassinet	Olympic Medical Corp.	LBI	Class II	1997-09-24
K971256	Duo-Lite Phototherapy System	Air-Shields, Inc.	LBI	Class II	1997-09-24
K971038	Kontron Kolormon Plus ECG with Respiration Module	Kontron Instruments, Inc.	DPS	Class II	1997-09-24
K973266	Z Deq-II	Electone, Inc.	ESD	Class I	1997-09-23
K972439	Anorectal Manometry Analysis Module	Medtronic-Synectics	FFX	Class II	1997-09-23
K972426	Microspan Gold Hysteroscope and Microspan Hysteroscope Sheath	Imagyn Medical, Inc.	HIH	Class II	1997-09-23
K972399	Advantage Windows Volume Rendering Option	GE Healthcare	JAK	Class II	1997-09-23
K972397	Ez Spray	Intertex Research, Inc.	CCQ	Class I	1997-09-23
K972368	Fotona Skinlight Plus Nd: Yag System	Medical Laser Solutions	GEX	Class II	1997-09-23
K972366	Imnet Dicom Network Agent	Imnet Systems, Inc.	LMD	Class I	1997-09-23
K972361	V40 Zirconia Femoral Heads	Howmedica Corp.	LZO	Class II	1997-09-23
K972360	Multispect 2 511 Kev Collimator	Siemens Medical Solutions USA, Inc.	KPS	Class II	1997-09-23
K971229	Capnoxygen Mask	Medsys, S.A.	CCK	Class II	1997-09-23
K971150	Mist Panoramic Laparoscope a Rigid Laparoscope	Mist, Inc.	GCJ	Class II	1997-09-23
K970906	Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus Multiparameter Sensor	Diametrics Medical, Inc.	CBZ	Class II	1997-09-23
K964467	Shelhigh Pericardial Patch	Shelhigh, Inc.	DXZ	Class II	1997-09-23
K963071	Angiomat Illumena	Mallinckrodt Inc., Liebel-Flarsheim Business	DXT	Class II	1997-09-23
K973069	Synchron Systems Methadone Reagent	Beckman Instruments, Inc.	DJR	Class II	1997-09-22
K972969	Quick-Draw Capillary Whole Blood Collection System	Innovative Medical Technologies, Inc	GIO	Class I	1997-09-22
K972963	Modified Cedia Dau Pcp Assay	Boehringer Mannheim Corp.	LCM	Unclassified	1997-09-22
K972743	Sigma Diagnostics Creatinine Reagent, Sigma Diagnostics Creatinine Reagent	Sigma Diagnostics, Inc.	CGX	Class II	1997-09-22
K972631	Ics Medical Vemr Video Eye Movement Recorder	Ics Medical Corp.	GWN	Class II	1997-09-22
K972580	Deoxypyridinoline Assay for the Bayer Immuno 1 System	Bayer Corp.	JMM	Class I	1997-09-22
K972462	Afp Assay for the Bayer Immuno 1 System	Bayer Corp.	LOJ	Class II	1997-09-22
K972436	T1 Line Dental Handpieces	Siemens Corp.	EFB	Class I	1997-09-22
K970885	Ultrasound Systems Drape	Protek Medical Products, Inc.	MMP	Class II	1997-09-22
K970877	Immulite Cea	Siemens Healthcare Diagnostics Inc.	DHX	Class II	1997-09-22
K973114	Silicone Biliary Stent/biliary Catheter	Specialty Surgical Products, Inc.	FGE	Class II	1997-09-19
K972958	Lysonix Ttd Delta Scavenger Suction/aspiration Cannulas Lysonix Infusion Diamond Cannulas	Lysonix, Inc.	GCJ	Class II	1997-09-19
K972901	American Biosurgical Electrosurgical Bipolar Cable/cord	American Biosurgical, Inc.	GEI	Class II	1997-09-19
K972785	Conform No Powder (Protein Labeling Claim) Examination Gloves	Ansell Perry	LYY	Class I	1997-09-19
K972781	Ot-1	Prism Therapeutics, LLC	FED	Class II	1997-09-19
K972692	Marchetti-Vicenzi Intramedullary Nail, Humeral	Zimmer GmbH	HSB	Class II	1997-09-19
K972679	Endopath Endoscopic Tissue Fastening System (Etfs)	Ethicon Endo-Surgery Inc	GCJ	Class II	1997-09-19