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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 420 of 3528

510(k) clearances, page 420 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K191550	Broncholab	Fluidda NV	JAK	Class II	2020-03-04
K191525	KinematX Total Wrist Arthroplasty System	Extremity Medical, LLC	JWJ	Class II	2020-03-04
K190509	Lubrina 2	J. Morita USA, Inc.	EFB	Class I	2020-03-04
K200275	OVision Imaging System	Ophthalmic Labs, Inc.	NFJ	Class II	2020-03-03
K193358	MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)	Siemens Healthcare Diagnostics Inc.	LTT	Class II	2020-03-03
K193064	Atlantis suprastructures	Dentsply Sirona Inc	NHA	Class II	2020-03-03
K192032	Fixone Biocomposite Small Anchor	Aju Medical Co., Ltd.	MAI	Class II	2020-03-03
K193532	LIAISON Anti-HAV Assay	Diasorin Inc.	LOL	Class II	2020-03-02
K193378	CarboClear Lumbar Cage System	CarboFix Orthopedics Inc.	MAX	Class II	2020-03-02
K193356	BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider	Medtronic, Inc.	GEI	Class II	2020-03-02
K193256	Anjon Bremer Halo System	G-5 Florida LLC	JEC	Class II	2020-03-02
K192637	High Strength Suture	Yunyi (Beijing) Medical Device Co., Ltd.	GAT	Class II	2020-03-02
K192506	Vantage Galan 3T, MRT-3020, V6.0	Canon Medical Systems Corporation	LNH	Class II	2020-03-02
K191872	Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution	Menicon Co. Ltd.	LPN	Class II	2020-03-02
K183425	Cardiovit at-102 G2	Schiller, AG	DPS	Class II	2020-03-02
K190304	Kingon P2 Oxygen Concentrator	Qingdao Kingon Medical Science and Technology Co.,Ltd	CAW	Class II	2020-02-29
K200381	Daytona® Small Stature Spinal System	SeaSpine Orthopedics Corporation	NKB	Class II	2020-02-28
K200284	R-Sensor, R-Sensor	Remedi Inc.	MUH	Class II	2020-02-28
K200225	Arctic Sun Stat Temperature Management System	Medivance Inc.	DWJ	Class II	2020-02-28
K200221	CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor	Mick Radio-Nuclear Instruments, Inc.	JAQ	Class II	2020-02-28
K193550	Therm-X	Zenith Technical Innovations, LLC	IRP	Class II	2020-02-28
K193483	Basal-IQ Technology	Tandem Diabetes Care, Inc.	QJS	Class II	2020-02-28
K193416	Cellvizio I.V.E. with Confocal Miniprobes	Mauna Kea Technologies	OWN	Class II	2020-02-28
K193243	Alta Multipurpose Device	Qfix	IYE	Class II	2020-02-28
K193029	Conquest Fn	Smith & Nephew, Inc.	JDO	Class II	2020-02-28
K192962	icobrain-ctp	icometrix	LLZ	Class II	2020-02-28
K192820	SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)	MEDLINE INDUSTRIES, LP - Northfield	KGO	Class I	2020-02-28
K192660	Zimmer M/L Taper Hip Prosthesis	Zimmer GmbH	LZO	Class II	2020-02-28
K192570	Atlas Spine Expandable Cervical Standalone Interbody System	Atlas Spine, Inc.	OVE	Class II	2020-02-28
K192496	Magnetom Sola, Magnetom Altea and Magnetom Sola Fit	Siemens Medical Solutions USA, Inc.	LNH	Class II	2020-02-28
K192447	Superelastic Staple	Neosteo	JDR	Class II	2020-02-28
K192346	scaffolene CL100 Bioresorbable Collagen Matrix	Freudenberg Technology Innovation SE & Co. KG	KGN	Unclassified	2020-02-28
K192247	Steripath Gen2 Blood Collection System	Magnolia Medical Technologies, Inc.	JKA	Class II	2020-02-28
K191928	AccuContour	Xiamen Manteia Technology, Ltd.	QKB	Class II	2020-02-28
K191556	Red Dot	Behold.Ai Technologies Limited	QFM	Class II	2020-02-28
K191555	HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length	Ethicon Endo-Surgery Inc	LFL	Unclassified	2020-02-28
K191246	Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)	Chalice Medical Ltd	DTZ	Class II	2020-02-28
K183680	i-STAT CHEM8+ cartridge with the i-STAT 1 System	Abbott Medical	JPI	Class II	2020-02-28
K200247	Fusion Quattro Extraction Balloon	Wilson-Cook Medical Inc.	GCA	Class II	2020-02-27
K200206	AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter	Stryker Corp.	QJP	Class II	2020-02-27
K193313	Elecsys Anti-TSHR	Roche Diagnostics GmbH	JZO	Class II	2020-02-27
K193274	Rodo Abutment System	Rodo Medical, Inc	NHA	Class II	2020-02-27
K193268	APrioCore Plus	AprioMed AB	KNW	Class II	2020-02-27
K193242	Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories	Masimo Corporation	MWI	Class II	2020-02-27
K192876	INTELLIO Tablet Application	Smith & Nephew, Inc.	ODA	Class II	2020-02-27
K192804	CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm	Medos International SARL	QJP	Class II	2020-02-27
K192683	Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads	Biomet U.K., Ltd.	LZO	Class II	2020-02-27
K192619	Pitkar Locked Plating System	S.H.Pitkar Orthotools Pvt., Ltd.	HRS	Class II	2020-02-27
K192305	Colibri Endoscopy System	3NT Medical Ltd.	EOB	Class II	2020-02-27
K192096	Omnia Medical Trauma Screws	Omnia Medical	HWC	Class II	2020-02-27