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 1036 of 3531

510(k) clearances, page 1036 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K093804	Nuvasive Helix Revolution Acp System	NuVasive Inc	KWQ	Class II	2010-02-19
K093789	Intouch Diabetes	Symcare Personalized Health Solutions, Inc.	NBW	Class II	2010-02-19
K093759	Multiple Name Model Multiple	Gx Corporation Sdn Bhd (Plant 1)	LZA	Class I	2010-02-19
K093721	Cosp2	3M Espe AG Dental Products	MVL	Unclassified	2010-02-19
K093712	Fora G71a Blood Glucose Monitoring System, Td-4274 Blood Glucose Monitoring System	Taidoc Technology Corporation	NBW	Class II	2010-02-19
K093339	Eli Pc Electrocardiograph	Mortara Instrument, Inc.	DPS	Class II	2010-02-19
K093318	Accelerator Aps	Abbott Medical	CEM	Class II	2010-02-19
K092295	Pioneer Posterior Cervico-Thoracic System	RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)	KWP	Class II	2010-02-19
K091951	Hammerlock	Biomedical Ent., Inc.	HTY	Class II	2010-02-19
K090917	Sureconnect Closed Drug Reconstitution and Transfer System	Baxa Corp.	LHI	Class II	2010-02-19
K100169	Duraspan Hemodialysis Long-Term Catheter	R4 Vascular, Inc.	MSD	Class II	2010-02-18
K093793	Ls-40 CO2 Laser System Model Ls-40	Sandstone Medical Technologies, LLC	GEX	Class II	2010-02-18
K093635	Models Fora V30 and Td-4242 Blood Glucose Monitoring Systems	Taidoc Technology Corporation	NBW	Class II	2010-02-18
K093447	Carrigen	Etex Corp.	MQV	Class II	2010-02-18
K091678	Hg II Short Fixture System	OSSTEM Implant Co., Ltd.	DZE	Class II	2010-02-18
K091029	Cleaner Rotational Thrombectomy System (9 Mm X 65 Cm) and (9 Mm X 120 Cm)	Rex Medical LP	MCW	Class II	2010-02-18
K083460	Dialog with Adimea Option	B. Braun Avitum AG	KDI	Class II	2010-02-18
K100290	Estemp Ne	Spident Co., Ltd.	EMA	Class II	2010-02-17
K100251	G-Cath Tissue Anchor Delivery Catheter, Models 205302, 205333	Usgi Medical	GAT	Class II	2010-02-17
K100242	Auto Suture Endo Clip Iii5mm Clip Adapter	Surgical Devices, A Division of Tyco Healthcare	FZP	Class II	2010-02-17
K100218	Biatain Agfoam Dressings-Non-Adhesiv: 5X7cm, 10X10cm, 10X20cm,15x15cm & 20X20cm	MEDLINE INDUSTRIES, LP - Northfield	FRO	Unclassified	2010-02-17
K100138	Zodiac Polyaxial Spinal Fixation System	Alphatec Spine, Inc.	MNI	Class II	2010-02-17
K093900	Edgelock	TORNIER Inc.	HRS	Class II	2010-02-17
K093865	Sensititre 18-24Hr Susceptibility Plates	Trek Diagnostic Systems, Ltd.	JWY	Class II	2010-02-17
K093711	Racegel	Septodont	MVL	Unclassified	2010-02-17
K093650	Biotrend Oxygen Saturation and Hematocrit System	Medtronic, Inc.	DTY	Class II	2010-02-17
K093533	Zimmer Patient Specific Instruments System, Version 2.0	Materialise N.V.	MBH	Class II	2010-02-17
K093470	Core-Flo D/c	Bisco Inc	EBF	Class II	2010-02-17
K093294	Revere Stabilization System	Globus Medical, Inc.	NKB	Class II	2010-02-17
K093188	Afm Ultra Ag Dressings	Milliken & Co.	FRO	Unclassified	2010-02-17
K093120	Xenium Xpm 110, Xenium Xpm 130, Models M25649a, M25650a, Xenium Xpm 150, Xenium Xpm 170	Baxter Healthcare Corporation - Renal Division	KDI	Class II	2010-02-17
K093064	Tumark Professional, Model 271560, Mr-Tumark Professional, Model 601560	SOMATEX Medical Technologies GmbH	NEU	Class II	2010-02-17
K092590	Pds Plates	Ethicon, Inc	NHB	Class II	2010-02-17
K092227	Jarit, Ruggles, R&b Redmond/ Redmond, Miltex, Meisterhand - Kerrison Rongeurs	Integra LifeSciences Corporation	HAE	Class II	2010-02-17
K092175	The Crosser S6 Catheter, the Crosser System Electronics, Model Crus6, Gen200	Flowcardia, Inc.	PDU	Class II	2010-02-17
K092028	Philips Avalon Fetal Monitors Fm20, Fm30, Fm40, and Fm50	Philips Medizin Systeme Boeblingen GmbH	HGM	Class II	2010-02-17
K093824	Full Automatic (Nibp) Blood Pressure Monitor, Model Hl158bt	Health & Life Corporation	DXN	Class II	2010-02-16
K093544	Tropazone Cr	Midlothian Laboratories	FRO	Unclassified	2010-02-16
K093515	3 Piece Parodi Guidewire System ( Long Cut Outer with Long Taper .014) Short Taper, 2 Piece Parodi Guidewire System (Lon	Brivant, Ltd.	DQX	Class II	2010-02-16
K093329	Scope Introducer Model 7400	N.M. Beale Co., Inc.	ODC	Class II	2010-02-16
K092870	Non-Sterile Disposable Vaginal Speculum	Kunshan Deyi Plastic Co., Ltd.	HIB	Class II	2010-02-16
K092805	Collagen Sponge	Innocoll Pharmaceuticals	KGN	Unclassified	2010-02-16
K091234	Skeltex Isv	Skeltex Technologies, Inc.	NDN	Class II	2010-02-16
K100207	Non-Mydriatic Retinal Camera, Model Trc-Nw8f	Topcon Corp.	HKI	Class II	2010-02-12
K100122	Modification to Capsure Ps System	Spine Wave Inc	MNH	Class II	2010-02-12
K100078	Modified Straight Fire Laser Fiber	Boston Scientific Corporation	GEX	Class II	2010-02-12
K100061	Cayman Screws Model K2-12-1000-Xx, K2-12-1001-Xx	K2M, Inc	KWQ	Class II	2010-02-12
K094019	Glider Pta Balloon Catheter	Trireme Medical, Inc.	DQY	Class II	2010-02-12
K093696	Sr Glove, Nu Glove, Highstress Model 801, Model 802, Model 803	Central Medicare Sdn Bhd	LZA	Class I	2010-02-12
K093631	B12 Reagent Cartridge and Fol Flex Reagent Cartridge, Model Rf642 and Rf644	Siemens Healthcare Diagnostics Inc.	CDD	Class II	2010-02-12