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 2026-10-29, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 812 of 3530

510(k) clearances, page 812 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K130686	Nasal Comfort Freedom	Lakeview Sleep Center	BZD	Class II	2013-10-16
K130644	Pediatric Folding Wheelchair	Columbia Medical Mfg, LLC	LBE	Class I	2013-10-16
K130294	Braemar Cardiokey Holter Recorder	Braemar Manufacturing, LLC	MWJ	Class II	2013-10-16
K130254	Prow Fusion	Nlt Spine, Ltd.	MAX	Class II	2013-10-16
K122949	Medline Suction Coagulator	MEDLINE INDUSTRIES, LP - Northfield	GEI	Class II	2013-10-16
K131993	Multichem U	Techno-Path Manufacturing Ltd.	JJY	Class I	2013-10-15
K131991	Endochoice Hot Biopsy Forceps	Boston Scientific Corporation	KGE	Class II	2013-10-15
K131234	Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)	Broncus Medical Inc	EOQ	Class II	2013-10-15
K130231	Non-Contact Infrared Thermometer	Jinxinbao Electronic Co.,Ltd	FLL	Class II	2013-10-15
K132885	Turbo-Ject Peripherally Inserted Central Venous Catheter (Picc) Set	Cook Incorporated	LJS	Class II	2013-10-11
K132619	Classic Intermittent Catheter	Flexicare Medical Ltd.	EZD	Class II	2013-10-11
K132560	Pcp-Usb Stethoscope	Rnk Products, Inc.	DQD	Class II	2013-10-11
K132405	Ppa/bt-Rb Stethoscope	Rnk Products, Inc.	DQD	Class II	2013-10-11
K132235	Imdx C.difficile for Abbott M2000	Intelligent Medical Devices, Inc.	OZN	Class II	2013-10-11
K132161	Optetrak Logic Ps 17Mm & 19Mm Thick Inserts, Optetrak Logic Psc 17Mm & 19Mm Thick Inserts	Exactech, Inc.	JWH	Class II	2013-10-11
K132145	Mtm(r) Clear Aligner	Dentsply International, Inc.	NXC	Class II	2013-10-11
K131908	2008T Hemodialysis Machine with Optional Crit-Line Monitor (Clic)	Fresenius Medical Care Renal Therapies Group, LLC	KDI	Class II	2013-10-11
K131807	High Energy Linear Accelerator	Varian Medical Systems, Inc.	IYE	Class II	2013-10-11
K131677	Precice Intramedullary Limb Lengthening System	Ellipse Technologies, Inc.	HSB	Class II	2013-10-11
K131534	Katana Zirconia	Kuraray Noritake Dental, Inc.	EIH	Class II	2013-10-11
K131502	Seattle - Pap	Seattle Childrens Hospital	BZD	Class II	2013-10-11
K131437	Modified Concentric Microcatheter	Concentric Medical, Inc.	DQO	Class II	2013-10-11
K131366	Accu-Chek Aviva Expert Blood Glucose Monitoring System	Roche Diagnostics GmbH	LFR	Class II	2013-10-11
K131337	Balanced Knee System High Flex Vitamin E Ps Tibial Insert and Patella	Ortho Development Corp.	JWH	Class II	2013-10-11
K131023	Theraflow Single Lumen and Theraflow Dual Lumen	Medical Products, Inc.	NFB	Class II	2013-10-11
K130881	Acuson S2000 and S3000	Siemens Medical Solutions USA, Inc.	IYN	Class II	2013-10-11
K130858	Reverse Medical Microcatheter	Reverse Medical Corporation	DQY	Class II	2013-10-11
K130660	Audicor Cpam with Sdb (Single Sensor)	Inovise Medical, Inc.	MLO	Class II	2013-10-11
K130123	Basic and Dominant Flex Suction Pumps	Medela AG	BTA	Class II	2013-10-11
K132482	Barricade Embolization Coil System	Blockade Medical	HCG	Class II	2013-10-10
K132412	Inertia Mis Pedicle Screw System	Nexxt Spine LLC	MNI	Class II	2013-10-10
K132303	Implanet Spine System	Implanet	OSH	Class II	2013-10-10
K132139	Deltex Medical Cardioq-Edm+	Deltex Medical Limited	DPW	Class II	2013-10-10
K131797	3B Laser Needle	Livetec GmbH	ILY	Class II	2013-10-10
K131779	Vitek 2 Ast-St Tigecycline	bioMerieux, Inc.	LON	Class II	2013-10-10
K131739	Nxstage Connected Health System	NxStage Medical Inc	FKP	Class II	2013-10-10
K131684	Biolox(r) Delta Ceramic Heads	Zimmer GmbH	LZO	Class II	2013-10-10
K131662	Immulite 2000 Acth Calibration Verification Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2013-10-10
K131636	Polarus Connect	Acumed LLC	LXT	Class II	2013-10-10
K131422	Peerscope System	Boston Scientific Corporation	FDS	Class II	2013-10-10
K131365	T2 Tibial Nailing System	Stryker Trauma GmbH	HSB	Class II	2013-10-10
K131178	Idys Lif Cages	Clariance, Inc.	MAX	Class II	2013-10-10
K130728	Polarstem Standard and Lateral Femoral Stems with Ti/ha	Smith & Nephew, Inc.	LZO	Class II	2013-10-10
K132819	Playtex (Scented and Unscented) Sport Fresh Balance Tampons	Playtex Manufacturing Inc.	HIL	Class II	2013-10-09
K132704	Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate Narrow	Zimmer GmbH	LXT	Class II	2013-10-09
K132667	Synergy Odm	Topcon Healthcare, Inc.	NFJ	Class II	2013-10-09
K132010	Vidas C Difficile Gdh	bioMerieux, Inc.	MCB	Class I	2013-10-09
K131981	Cezanne II Interbody Fusion System	Accel Spine	MAX	Class II	2013-10-09
K131774	Hamilton-G5	Hamilton Medical AG	CBK	Class II	2013-10-09
K131546	Au Bicarbonate Reagent	Beckman Coulter Ireland Inc	KHS	Class II	2013-10-09