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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2556 of 3530

510(k) clearances, page 2556 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K893203	Bone Screw	Karlin Technology, Inc.	JDR	Class II	1990-04-04
K893201	Bone Plate	Karlin Technology, Inc.	HRS	Class II	1990-04-04
K901359	Vital Surgical Gloves	Mastervest Corp. Sdn Bhd.	KGO	Class I	1990-04-03
K901296	Cedia (Tm) Cortisol Assay	Microgenics Corporation	CGR	Class II	1990-04-03
K901248	Abc Handpiece Adapter	Beacon Laboratories, Inc.	HAM	Class II	1990-04-03
K901135	Enzymun Test(r) Insulin	Boehringer Mannheim Corp.	CFP	Class I	1990-04-03
K901057	Spirometrics Model 2600 Miro Spirometer	Spirometrics, Inc.	BZG	Class II	1990-04-03
K900905	Technicon Axon System Reagent Methods	Technicon Instruments Corp.	CKA	Class I	1990-04-03
K900779	Enzymun Test(r) Lh	Boehringer Mannheim Corp.	CEP	Class I	1990-04-03
K900776	Novapath Microplate Reader	Bio-Rad	JJQ	Class I	1990-04-03
K900700	Smu 611 Universalmonitor	Ppg Industries, Inc.	DPS	Class II	1990-04-03
K900676	Csf-Flow Control Valve, Cylindrical & Shunt Kit	Pudenz-Schulte Medical Research Corp.	JXG	Class II	1990-04-03
K900673	Serial Flow	Spirometrics, Inc.	BZG	Class II	1990-04-03
K900672	Prebypass Filter, Cat. No. Fpb-5	American Omni Medical, Inc.	KRJ	Class II	1990-04-03
K900292	Snap M. Tuberculosis Complex	Syngene, Inc.	LQF	Class I	1990-04-03
K900231	Coulter Calcium Reagent	Coulter Corp.	CJY	Class II	1990-04-03
K900230	Coulter Amylase Reagent	Coulter Corp.	JFJ	Class II	1990-04-03
K900204	Avi Model 840 Dual Channel Infusion Pump	3M Company	FRN	Class II	1990-04-03
K900202	Snap Mycobacteria Avium Complex	Syngene, Inc.	LQF	Class I	1990-04-03
K900089	Fg Diamond Burrs	Kab Gloves Unltd.	DZP	Class I	1990-04-03
K900068	Aristee (Resin, Crown and Bridges)	Prometex, Inc.	EBG	Class II	1990-04-03
K900010	Nds Cortisol Test Kit and Nds Cortisol Calibrator	Kallestad Diag, A Div. of Erbamont, Inc.	JFT	Class II	1990-04-03
K897147	Sigma Procedure No. 735	Sigma Diagnostics, Inc.	KHP	Class I	1990-04-03
K896631	Exec-Wash Solid Phase Washing System	Source Scientific Systems, Inc.	JQW	Class I	1990-04-03
K896300	Ldw Spirometry System	Lanpher Diagnostic Workstations, Inc.	BZG	Class II	1990-04-03
K895818	Steadfast Denture Adhesive Cream	Stiefel Research Institute, Inc.	KOT	Class I	1990-04-03
K890486	Mxr-14 Film Processor	Cordell, Inc.	IXW	Class II	1990-04-03
K901333	Beta-2 Microglobulin Eia	Serex, Inc.	JZG	Class II	1990-04-02
K901075	Lumatag(tm) Ferritin Chemiluminescence Immunomet.	London Diagnostics, Inc.	DBF	Class II	1990-04-02
K901014	Radiographic Intensifying Screen	Infab, LLC.	EAM	Class I	1990-04-02
K900360	Saxon Ultra Thin	Safetex Corp.	HIS	Class II	1990-04-02
K900359	Embrace	Safetex Corp.	HIS	Class II	1990-04-02
K900358	Saxon Wet Lube	Safetex Corp.	HIS	Class II	1990-04-02
K900357	Gold Circle Coin	Safetex Corp.	HIS	Class II	1990-04-02
K900184	Lingual Sheath	Ormco Corp.	EJF	Class I	1990-04-02
K900117	Stellite Cobalt/chromium Base Metal Alloy	D.C. Dental Specialties	EJH	Class II	1990-04-02
K900078	Simultest Imk Plus(tm)	BD Becton Dickinson Vacutainer Systems Preanalytic	GKZ	Class II	1990-04-02
K900029	Spectrastim 2000 Muscle Stimulator	Therapeutic Technologies, Inc.	IPF	Class II	1990-04-02
K900002	Doppler Option for Platinum	Philips North America LLC	DXK	Class II	1990-04-02
K895700	Ameda/egnell Dolphin Dispo-Soft Vacuum Extractor	Hollister, Inc.	HDB	Class II	1990-04-02
K895487	Temporary Dental Cement	Dentsply Intl.	EMA	Class II	1990-04-02
K895347	Microruptor III System, Cw Nd: Yag Laser Component	Lasag Medical Lasers	GEX	Class II	1990-04-02
K895085	Walklite Protable Re-Chargeable Curing Light	Lustgarten Multi-Tech International, Inc.	EBZ	Class II	1990-04-02
K901295	Pulmonair 40 Patient Management System	Medical Group	IOQ	Class II	1990-03-30
K901129	Bio-Mate(tm) Pediatric Epidural Catheter	Medevice, Inc.	BSO	Class II	1990-03-30
K901086	Enzymun Test(r) T4 (Total Thyroxine)	Boehringer Mannheim Corp.	KLT	Class II	1990-03-30
K900778	Item #272 Magnif-Eyes Contact Lens Case	FGX International Inc.	LRX	Class II	1990-03-30
K900777	Item #273 Contact Lens Cases	FGX International Inc.	LRX	Class II	1990-03-30
K900695	Enzymun Test(r) Prolactin	Boehringer Mannheim Corp.	CFT	Class I	1990-03-30
K900641	Cannula, Suction Uterine	Williams Specialty Products, Inc.	HHI	Class II	1990-03-30