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 958 of 3531

510(k) clearances, page 958 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K110953	Visensia, Visensia with Alert	OBS Medical Ltd	MHX	Class II	2011-06-15
K110864	Biospine Vbr System	Aesculap Inc	MQP	Class II	2011-06-15
K110297	Powder Free Nitrile (Black) Examination Gloves	Comfort Rubber Gloves Industries Sdn Bhd	LZA	Class I	2011-06-15
K110171	Nobelprocera Zi Abutment Thommen Platforms	Nobel Biocare USA LLC	NHA	Class II	2011-06-15
K103594	Ponto Pro Power	Oticon Medical AB	LXB	Class II	2011-06-15
K102949	Colonoscopy Assistant	Sti Medical Systems	FET	Class II	2011-06-15
K102274	Arvik Laparoscopic Aspiration Instrument	Arvik Enterprises/ Mini Lap Technologies	GAA	Class I	2011-06-15
K111244	Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc)	Cook Inc.	LJS	Class II	2011-06-14
K111217	Additive Cap	Baxter Healthcare Corporation	KPE	Class II	2011-06-14
K111078	Aeu-26L Elctronic Endodontic System	Aseptico, Inc.	EKX	Class I	2011-06-14
K110747	Tempflex	Sybron Dental Specialties, Inc.	EBG	Class II	2011-06-14
K110739	Entellus Medical Sinus Guidewire	Entellus Medical, Inc.	LRC	Class I	2011-06-14
K110599	Aequalis Ascend Modular Reverse Shoulder System	TORNIER Inc.	PHX	Class II	2011-06-14
K110597	Ev1000 Clinical Platform	Edwards Lifesciences LLC	DXG	Class II	2011-06-14
K110001	Spacelabs Pathfinder Sl Holter Analyzer	GE Healthcare	DQK	Class II	2011-06-14
K100313	Hydrofix Surgical Sheet	Mimedx Group, Inc.	FTL	Class II	2011-06-14
K110933	Spineology Peek Lumbar Interbody Fusion Device	Spineology, Inc.	MAX	Class II	2011-06-13
K110927	Mectalif	Medacta International SA	MAX	Class II	2011-06-13
K110374	Max Pulse System	Medicore Co. Ltd.	JOM	Class II	2011-06-13
K102507	Area-CT, Tz Medical Mcot ECG Monitor and Arrhythmia Detector	TZ Medical Inc.	DSI	Class II	2011-06-13
K102458	4Cis Solar Spine System and 4Cis Apollon Spine System	Solco Biomedical Corp.	MNH	Class II	2011-06-13
K101990	Ethicon Endo-Surgery Generator G11, Model Gen11	Ethicon Endo-Sugery, LLC	GEI	Class II	2011-06-13
K111471	Exoshape (Tm) Interference Fixation Device Model 1100-00-Xxxx (Varies by Size)	Medshape, Inc.	MBI	Class II	2011-06-10
K111344	I5 Digital X-Ray Imaging System (with Flaatz 560)	Infimed, Inc.	OWB	Class II	2011-06-10
K111023	Abbott Architect Lh Calibrators	Abbott Medical	JIT	Class II	2011-06-10
K110969	Powder Free Vinyl Patient Examination Gloves, Clear (Non-Colored)	Ppp Medical and Safety Products Company Limited	LYZ	Class I	2011-06-10
K110936	Duraflow 2 Chronic Hemodialysis Catheter and Procedure Kit	Boston Scientific Corporation	MSD	Class II	2011-06-10
K110759	Tempocem	Dmg USA, Inc.	EMB	Class I	2011-06-10
K110640	Atlantis Abutment for Camlog Implant, Duplicate Abutment, Later Abutment	Astra Tech, Inc.	NHA	Class II	2011-06-10
K110356	Atlantis Crown Abutment, Atlantis Gemini +(Tm) Abutment	Astra Tech, Inc.	NHA	Class II	2011-06-10
K110274	Autodelfia Neonatal Irt Kit	Wallac Oy, A Subsidiary of Perkinelmer, Inc.	JNO	Class I	2011-06-10
K110248	Powder Free Nitrile Patient Examination Gloves, White Color	Jiangsu Dongling Plastic & Rubber Co., Ltd.	LZA	Class I	2011-06-10
K110247	Powder Free Nutrile Patient Examination Gloves, Blue Color	Jiangsu Dongling Plastic & Rubber Co., Ltd.	LZA	Class I	2011-06-10
K110133	Empira Rx Ptca Dilatation Catheter, Empria Nc Rx Ptca Dilatation Catheter	Creganna-Tactx Medical	LOX	Class II	2011-06-10
K110119	Pressure Manometer	Neoforce Group, Inc.	CAP	Class II	2011-06-10
K110088	Defendo Y-Opsy Irrigator	Byrne Medical Incorporated	ODC	Class II	2011-06-10
K103736	Dmc Medical Single-Use Polycarbonate Syringe	DMC Medical Ltd.	FMF	Class II	2011-06-10
K103601	Audit Microcv Immunoassay Linearity Set	Aalto Scientific Ltd.	JJY	Class I	2011-06-10
K103584	Envisen Nellcor, Bci, Nonin, Csi, Hp/philips, Datex-Ohmeda Compatible Disposable and Reusable Spo2 Sensors	Shenzhen Envisen Industry Co. Ltd.	DQA	Class II	2011-06-10
K102625	Vega CPAP System/heated Humidifier, Model Cp-03	Vega Technologies Inc.	BZD	Class II	2011-06-10
K102389	Navigator Applications Suite	GE Healthcare Finland Oy	BSZ	Class II	2011-06-10
K102258	Cusa Nxt Extended Length Tip	Integra Radionics, Inc.	LFL	Unclassified	2011-06-10
K111349	Elecsys Shbg Calcheck 5	Roche Diagnostics GmbH	JJX	Class I	2011-06-09
K111092	Engage/engage Tr Introducers	Abbott Medical	DYB	Class II	2011-06-09
K111020	Atricure Dissector	AtriCure, Inc.	FTD	Class II	2011-06-09
K111016	Safeport Manifold (Tm) (or Stopcock)	Elcam Medical A.C.A.L.	FPA	Class II	2011-06-09
K110850	K-Pack II Needle- 27G & 30G Thin Wall	Terumo Europe N.V.	FMI	Class II	2011-06-09
K110394	Atac Serum Calibrator (Direct Bilirubin and Iron)	Vital Diagnostics (Manufacturing) Ptyltd	JIX	Class II	2011-06-09
K110273	Aerovent Plus Chc	Monaghan Medical Corp.	CAF	Class II	2011-06-09
K103019	Kj Mask	KJ Meditech Co., Ltd.	DZB	Class II	2011-06-09