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 2026-11-05, 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 2154 of 3531

510(k) clearances, page 2154 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K935126	Nascor Igloo	Nascor Pty., Ltd.	BYL	Class I	1994-10-18
K934016	Powercharger	ZOLL Medical Corporation	DTE	Class II	1994-10-18
K926334	Axiom Total Knee Syst/acl Retain Tibial Tray/inser	Orthomet, Inc.	JWH	Class II	1994-10-18
K923946	Conchatherm IV Heated Molecular Humidifier	Hudson Respiratory Care, Inc.	BTT	Class II	1994-10-18
K944849	2700 Cleartrace Radiotranslucent Monitoring ECG Electrobe	Conmed Andover Medical, Inc.	DRX	Class II	1994-10-17
K944760	Dura-Y Oxygen Transducer, Ear Clip	Nellcor, Inc.	DPZ	Class II	1994-10-17
K944574	Lumex Wheelchairs (Ser. 1000, 3000, 4000, 5000, Tilt-in-Space, 6000, MRI)	Lumex, Inc.	IOR	Class I	1994-10-17
K944345	Bedside Butler	Trac Medical, Inc.	IQA	Class II	1994-10-17
K943586	Zirconia Ceramic Modular Heads (Astro Met)	Zimmer GmbH	LZO	Class II	1994-10-17
K943456	As/3 Nellcor Compatible Saturation Moodule, M-Nsat	Datex Division Instrumentarium Corp.	DQA	Class II	1994-10-17
K943342	Medicam Xenon Light Source	M.P. Video, Inc.	FSW	Class II	1994-10-17
K943288	Amsco Sq240 Surgical Light	American Sterilizer Co.	FSY	Class II	1994-10-17
K942871	Press-Mate Bp8800ms Automatic Non-Invasive Blood Pressure System	Colin Medical Instruments Corp.	DXN	Class II	1994-10-17
K941982	Capnocheck	Bci, Inc.	CCK	Class II	1994-10-17
K934684	Pam Cardiac Monitor	Technology Transfer, Inc.	DRT	Class II	1994-10-17
K930912	Hysteromed 100	Northgate Technologies Inc.	HIG	Class II	1994-10-17
K925195	Malibu Bathing System	Medi-Man Rehabilitation Products, Inc.	ILJ	Class II	1994-10-17
K922088	Fresenius Dialysate Acid Concentrate	Fresenius USA, Inc.	KPO	Class II	1994-10-17
K944837	Medical Device Technologies Manual Biopsy Needle	Medical Device Technologies, Inc.	KNW	Class II	1994-10-14
K944779	Carbon Lights Hand Surgery Table	Allen Medical Systems, Inc.	FWZ	Class I	1994-10-14
K944296	Karl Storz Optical Video Tongue Depressor	Karl Storz Endoscopy-America, Inc.	EOB	Class II	1994-10-14
K944175	Adam Shell Thermocouple Assembly	Pro-Tech Services, Inc.	BZG	Class II	1994-10-14
K943915	Heat and Moisture Exchanger Filter (Hme)	Medicomp, Inc.	BYD	Class I	1994-10-14
K943904	Rigid Telescopes	Karl Storz Endoskop GmbH	ENZ	Class II	1994-10-14
K943837	Chin Up	Edward Carden	CCX	Class I	1994-10-14
K943575	B-D Guardian Nestable Sharps Collectors	BD Becton Dickinson Vacutainer Systems Preanalytic	FMI	Class II	1994-10-14
K943474	Cannulated Bone Screw	Cohort Medical Products Group, Inc.	HWC	Class II	1994-10-14
K943302	Aml Tri-Lock Replacement Liner System	Depuy, Inc.	JDI	Class II	1994-10-14
K943021	Mrt-150A	Toshiba America Mri, Inc.	LNH	Class II	1994-10-14
K942966	Aml Trilock Replacement Liner System	Depuy, Inc.	JDI	Class II	1994-10-14
K941606	Preservation Unicompartmental Knee	Depuy, Inc.	HSX	Class II	1994-10-14
K940982	Arterial Embolization Device (Krd)	Cook Inc.	KRD	Class II	1994-10-14
K940927	Rescue Breather	O-Two Systems Intl., Inc.	CBP	Class II	1994-10-14
K940634	Micro Therapeutics Infusion Catheter	Medtronic, Inc.	FOZ	Class II	1994-10-14
K936232	Bsc/ca Model 930 Iab, Bsc/ca 30 Sidewinder	Boston Scientific Corporation	DSP	Class II	1994-10-14
K935593	Anatomic Proportional Shoulder Aps (Hemi-Shoulder) System	Biodynamic Technologies, Inc.	HSD	Class II	1994-10-14
K935090	Cuff-Cath	GE Healthcare	FOZ	Class II	1994-10-14
K934868	Lorad Transpo	Lorad Corp.	IZH	Class II	1994-10-14
K933942	Solution Bowed Femoral Hip Protsthesis	Depuy, Inc.	LZO	Class II	1994-10-14
K932677	Axiom Total Knee System	Orthomet, Inc.	JWH	Class II	1994-10-14
K931678	Orthomet Lhmc Femoral Stem	Orthomet, Inc.	HMC	Class II	1994-10-14
K931333	Orthomet Acetabular Cup System	Orthomet, Inc.	LPH	Class II	1994-10-14
K925613	Proximal Humeral Replacement System	Zimmer GmbH	KWT	Class II	1994-10-14
K925209	Mumps Stat	Biowhittaker Molecular Applications, Inc.	LJY	Class I	1994-10-14
K944782	Catco Urological Catheter	Catco Medical, Inc.	EZD	Class II	1994-10-13
K944770	Lsvp International Biopsy Forceps	Lsvp Intl., Inc.	FCL	Class I	1994-10-13
K944141	Comfit (Sterile)	Wembley Rubber Products (M) Sdn Bhd	LYY	Class I	1994-10-13
K943783	7 French Large Lumen Triguide-Plus	Scimed Life Systems, Inc.	DQY	Class II	1994-10-13
K943777	Scimed 8 French Big-Max Guide Catheter	Scimed Life Systems, Inc.	DQY	Class II	1994-10-13
K943672	Phaco Needles and Tips	MicroSurgical Technology Inc	HQC	Class II	1994-10-13