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 1951 of 3531

510(k) clearances, page 1951 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K962990	Radionics Siphon Limiting Device (Sld)	Radionics, Inc.	JXG	Class II	1996-10-23
K962945	Cordis Opta Pta Balloon Catheter	Cordis US Corp.	LIT	Class II	1996-10-23
K962944	Transtracheal Demand Oxygen Controller (Doc-2000)	Transtracheal Systems	NFB	Class II	1996-10-23
K962907	Skinny,franseen,wescott Needles	Baxter Healthcare Corporation	KNW	Class II	1996-10-23
K962871	Ods1 - Hood Driver	Reimers Systems, Inc.	CBF	Class II	1996-10-23
K962869	Gsp1 - Gas Selection Panel	Reimers Systems, Inc.	CBF	Class II	1996-10-23
K962846	Ez-Fix Compression Hip/supracondylar Screw (Chs) System	Biodynamic Technologies, Inc.	LXT	Class II	1996-10-23
K962713	Dpap Stealth Sleepnet Model Number 84000	SleepNet Corporation	BZD	Class II	1996-10-23
K962268	Chrome Cobalt Ball Head	Artos Medical Products GmbH	LWJ	Class II	1996-10-23
K962034	Sc, Cementless Hip System	Artos Medical Products GmbH	LWJ	Class II	1996-10-23
K961888	Pillar 4-Wheel Scooter	Pillar Technology, Inc.	INI	Class II	1996-10-23
K961844	Operating Arm System (Oas) [with CT and Mr Images]	Radionics Software Applications, Inc.	HAW	Class II	1996-10-23
K961247	As/3 Light Monitor	Datex Division Instrumentarium Corp.	DPS	Class II	1996-10-23
K960056	Usci Pro Flo Xt,soft Tip, and Xt Soft Tip Angiographic	C.R. Bard Inc	DQO	Class II	1996-10-23
K963333	Optronics Epic Color Television Camera System (S97340)	Karl Storz Imaging, Inc.	HKI	Class II	1996-10-22
K962881	Ksea Culdocentesis Set	Karl Storz Endoscopy-America, Inc.	HEW	Class II	1996-10-22
K962879	Salterlabs 8660 Series Nebulizer	Salter Labs	CAF	Class II	1996-10-22
K962645	Isola Twister Connector	Acromed Corp.	MNH	Class II	1996-10-22
K962426	Chrono-Log Whole Blood Aggregometer (Wba) 591/592	Chrono-Log Corp.	JOZ	Class II	1996-10-22
K955470	Action Potential Simulation Therapy Device	Neurotech, Inc.	GZJ	Class II	1996-10-22
K954651	Electrode Recording Catheter	Boston Scientific Corporation	DRF	Class II	1996-10-22
K963338	Unimed Suction-Irrigation Electrode and Sliding Sheath	Unimed Surgical Products, Inc.	GEI	Class II	1996-10-21
K963234	Staple Removal Kit	Continental Medical Laboratories, Inc.	GDT	Class I	1996-10-21
K963031	Genxcatheter	<Genx> Intl., Inc.	MFD	Class II	1996-10-21
K962931	Sims Pro-Vent 250 (500) Plus Arterial Blood Sampling Kit	Smiths Industries Medical Systems, Inc.	JKA	Class II	1996-10-21
K962920	Renton Suction Device u.s. Patent*4,767,404	R&S Surgical, LLC	GCX	Class II	1996-10-21
K962611	Bard Eagle Inflation Device	Ryder Intl. Corp.	KOE	Class II	1996-10-21
K962250	Carroll Healthcare Dlx 2300-111 Electric Bed	Carroll Healthcare, Inc.	FNL	Class II	1996-10-21
K961126	Pulse Dose Series	Devilbiss Health Care, Inc.	NFB	Class II	1996-10-21
K960810	Balloon Cannula 15Mm X 35Mm,15mm X 55Mm, 10/12Mm X 55Mm,10/12mm X 35Mm,5mm X 35Mm,2mm X 35Mm	Marlo Surgical Technology	HET	Class II	1996-10-21
K955299	Dps 4 Dialyzer Preparation System	Seratronics, Inc.	LIF	Class II	1996-10-21
K954492	Mercury Medical Expiratory Resistance Exerciser, Resistex	Mercury Medical	BWF	Class II	1996-10-21
K952083	Tec IV and Tec V Anesthesia Vaporizers for Sevoflurane	Clover Medical Equipment Services, Inc.	CAD	Class II	1996-10-21
K963856	Rand Nasal Packing	Rand Scientific Corp.	EMX	Class I	1996-10-18
K963630	C.o.l.d.a.	C.O.L.D.A. S.N.C.	HQY	Class I	1996-10-18
K963570	Sims Adult Lumbar Puncture Kit (4800-20,4801-20,4806-22,4807-22)	Smiths Industries Medical Systems, Inc.	FMJ	Class II	1996-10-18
K963569	Wheelchair Waist Belt, Medline Economy Wheelchair Belt, Medline Two-Piece Safety Soft Belt, Medline Wheelchair Belt with	MEDLINE INDUSTRIES, LP - Northfield	FMQ	Class I	1996-10-18
K963458	Padded Mitts/padded-Plus Mitts/finger Separator Padded Mitts/rigid Palm Padded Mitts	Skil-Care Corp.	FMQ	Class I	1996-10-18
K963452	Medline Zipper Sleeved Vest	Medline	FMQ	Class I	1996-10-18
K963408	Visualine D Hcg	Sun Biomedical Laboratories, Inc.	JHI	Class II	1996-10-18
K963404	Medline Pelvic Holder	MEDLINE INDUSTRIES, LP - Northfield	FMQ	Class I	1996-10-18
K963362	Medline Saety Vest,medline Economy Vest, Medline Tie-Back Vest, Medline Securtiy Vest, Vest Restraint	MEDLINE INDUSTRIES, LP - Northfield	FMQ	Class I	1996-10-18
K963360	Medline Body Holder	MEDLINE INDUSTRIES, LP - Northfield	FMQ	Class I	1996-10-18
K963353	Lysol I.c. Brand Phenolic Disinfectant Cleaner (Epa Reg. No. 675-46)	Reckitt Benckiser LLC	LRJ	Class I	1996-10-18
K963345	Advantage Windows Tissue Volume Option	GE Healthcare	LNH	Class II	1996-10-18
K963097	Clampless Valved Catheter-Picc (Cvc-Picc)	Bmw Medical, Inc.	LJS	Class II	1996-10-18
K963009	Deltec Subcutaneous Infusion Set	Sims Deltec, Inc.	FPA	Class II	1996-10-18
K962919	Vitros Immunodiagnostic System	Johnson & Johnson Clinical Diagnostics, Inc.	KHO	Class I	1996-10-18
K962893	Interlink Adapter for Conventional Y-Site	Baxter Healthcare Corporation	FPA	Class II	1996-10-18
K962877	Midwest 300 Se	Midwest Dental Products Corp.	EFB	Class I	1996-10-18