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 2517 of 3531

510(k) clearances, page 2517 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K903969	Suction Retractor(tower Attach.)for Crank Fram Ret	Karlin Technology, Inc.	GAD	Class I	1990-09-05
K903898	Quanta Lite Tm Dsdna	Inova Diagnostics, Inc.	LLL	Class II	1990-09-05
K903849	Model Rd-1200 Ruby Laser System	Charles L. Rose and Co., Inc.	GEX	Class II	1990-09-05
K903787	Avi Model 470Cm Infusion Pump	3M Avi, Inc.	FRN	Class II	1990-09-05
K903786	Avi Micro 845 Dual Channel Infusion Pump	3M Avi, Inc.	FRN	Class II	1990-09-05
K903785	Avi Model 400Cm Infusion Pump	3M Avi, Inc.	FRN	Class II	1990-09-05
K903783	Avi Micro 275Cm Infusion Pump	3M Avi, Inc.	FRN	Class II	1990-09-05
K903782	Avi Model 270Cm Infusion Pump	3M Avi, Inc.	FRN	Class II	1990-09-05
K903756	Sterile Patient Examination Gloves	Tillotson Rubber Co., Inc.	LYY	Class I	1990-09-05
K903746	Comfit, Patient Examination Gloves	Wembley Rubber Products (M) Sdn Bhd	FMC	Class I	1990-09-05
K903712	Flossie Toothfloss	Flossie, Inc.	JES	Class I	1990-09-05
K903295	Escort Itc	Hearing Tech, Inc.	ESD	Class I	1990-09-05
K903214	Oxygen, Air, Vacuum, and Nitrous Couplers	Medical Fittings, Inc.	EJF	Class I	1990-09-05
K903140	Puritan-Bennett Compan Emt W/remote Liq Lev Guage	Medtronic, Inc.	BYJ	Class II	1990-09-05
K902844	Nickel-Titanium Orthodontic Tooth Separating Sprin	Progressive Dental Supply	EJF	Class I	1990-09-05
K902708	Safety First	Bright Rubber Industries Private, Ltd.	LYY	Class I	1990-09-05
K902696	N-Dex	Moss Point Glove Co.	LYY	Class I	1990-09-05
K902670	Pm Gloves (Mfg: Bjl Glove (M) Sdn.bhd.)	PM Gloves, Inc.	LYY	Class I	1990-09-05
K902571	Modification of Serocard Rubella Igg Test	Disease Detection International, Inc.	LFX	Class II	1990-09-05
K902547	The Protector II, Laser Surgical Mask	Anago, Inc.	FXX	Class II	1990-09-05
K902546	The Protector & High Performance Splash Mask	Anago, Inc.	FXX	Class II	1990-09-05
K902349	Surgitek Intra-Span Intraoperative Tissue Expander	Surgitek	FZW	Class I	1990-09-05
K902220	Precipath(r) Im Normal & Abnormal Immuno. Control	Boehringer Mannheim Corp.	DGR	Class I	1990-09-05
K902177	Manan Bone Biopsy Needle	Argon Medical Devices, Inc	GDM	Class I	1990-09-05
K901974	Selector Ultrasonic Surgical Aspirator	Spembly Medical, Ltd.	LFL	Unclassified	1990-09-05
K901972	Add'l Claimed Intended Use for Ideia(tm) Chlamydia	Novo Nordisk Diagnostics, Ltd.	LJC	Class I	1990-09-05
K901835	Lake N/g Feeding Tube (with Y Port Connector)	Lake Medical Products, Inc.	KNT	Class II	1990-09-05
K901641	Axillobifemoral Gore-Tex Vascular Graft	W. L. Gore & Associates, Inc.	DSY	Class II	1990-09-05
K901467	Vision Diagnostic Ultrasonic Scanner	The Probe Corp.	IYO	Class II	1990-09-05
K901419	Dual Port	Infusaid Corp.	LJT	Class II	1990-09-05
K901253	(Pbs) Portable Bypass System, Model 1000	Bio Medicus, Inc.	DTZ	Class II	1990-09-05
K896652	Capnomac Ultima(tm) Anesthesia Monitor	Datex Division Instrumentarium Corp.	CCK	Class II	1990-09-05
K896524	Spirtos Coaxial Catheter Set	Cook Ob/Gyn	HET	Class II	1990-09-05
K903881	Ventlab Vent-Mask, Cat# Vr 0010/20/30	Salter Labs	BSJ	Class I	1990-09-04
K903788	Avi Micro 285Cm Infusion Pump	3M Avi, Inc.	FRN	Class II	1990-09-04
K903699	Passy-Muir Tracheostomy Speaking Valve 15Mm / 22Mm	Passy & Passy, Inc.	JOH	Class II	1990-09-04
K903657	Model 610 Modified	First Medical Devices Corp.	LDD	Class II	1990-09-04
K903576	Puck 90M	Elema-Schonander, Inc.	KPX	Class II	1990-09-04
K903528	Laparoscope	Intramed Laboratories, Inc.	HET	Class II	1990-09-04
K903422	Mt-15 Radiographic/fluoroscopic Tilt Table	Imt America, Inc.	IXR	Class II	1990-09-04
K903222	Biochem 6100 Non-Invasive Monitor	Biochem International, Inc.	DXN	Class II	1990-09-04
K903125	Puritan Bennett Single Patient Use PEEP Valve	Medtronic, Inc.	BYE	Class II	1990-09-04
K902962	Lifelog(tm)	Modular Instruments, Inc.	BSZ	Class II	1990-09-04
K902905	Cook Coronary Guiding Catheter	Cook Inc.	DQY	Class II	1990-09-04
K902802	Fetal Monitoring Transducer Strap	Macon & Co., Inc.	HGM	Class II	1990-09-04
K902755	.018 Hi-Torque Floppy Guide Wire W/ Preshaped Tip	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1990-09-04
K902738	Electro Blue ECG Electrode-Pediatric Cloth	Labeltape Meditect, Inc.	DRX	Class II	1990-09-04
K902716	Pe Electrophysiology Lab System (PEEP)	Prucka Engineering, Inc.	DQK	Class II	1990-09-04
K902632	Gas-Lyte 1Cc and 3Cc Arterial Blood Samplers	Marquest Medical Products, Inc.	CBT	Class I	1990-09-04
K902576	Alastat Allergen-Spec Ige Control Dc1a/2a/6a/ngca	Siemens Healthcare Diagnostics Inc.	DHB	Class II	1990-09-04