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 2293 of 3531

510(k) clearances, page 2293 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K931277	Hollister Premium Urine Collector	Hollister, Inc.	EXI	Class I	1993-06-23
K931164	Rusch Agt PVC Preform Nasal Trach Tub/cuf W/mur Ey	Rusch, Inc.	BTR	Class II	1993-06-23
K931163	Rusch Agt PVC Preform Oral Trach Tub/cuf W/mur Eye	Rusch, Inc.	BTR	Class II	1993-06-23
K930004	Escort 100/300 Series B Patient Monitors	Medical Data Electronics	DRT	Class II	1993-06-23
K924974	The Tmj Appliance	Myofunctional Research Corp. Pty. Ltd.	KMY	Class I	1993-06-23
K924529	Signature(tm) Custom Tubing Pack	Avecor Cardiovascular, Inc.	DWF	Class II	1993-06-23
K922891	Cordis 7 French Thrulumen Catheter	Cordis US Corp.	DQO	Class II	1993-06-23
K932282	Endopath II Disposable Surgical Trocar & Sleeve	Ethicon Endo-Surgery Inc	GCJ	Class II	1993-06-22
K932014	Ambu Disposable Face Mask	Ambu, Inc.	BSJ	Class I	1993-06-22
K931975	Audiotech Model Dp	Muskogee Regional Hearing Aid Lab	ESD	Class I	1993-06-22
K931761	Quickvue(tm) One-Step Hcg Controls (Posit/negati)	Ortho-Clinical Diagnostics, Inc.	JJX	Class I	1993-06-22
K931608	Nca-200	Ics Medical Corp.	KHH	Class I	1993-06-22
K931428	Cadwell 6200 a	Cadwell Laboratories, Inc.	GWF	Class II	1993-06-22
K931365	Dw207 #28G, Dw207 #35F, Dw207 #39Lc	Ivoclar North America, Inc.	EJT	Class II	1993-06-22
K931238	Endopath Disposable Knot Pusher	Ethicon, Inc	GCJ	Class II	1993-06-22
K931237	Endopath* Disposable Introducer	Ethicon, Inc	GCJ	Class II	1993-06-22
K931166	Rusch Agt PVC Pref Oral Trach Tube, Uncuf W/mur Ey	Rusch, Inc.	BTR	Class II	1993-06-22
K931165	Rusch Agt PVC Pref Nasal Trach Tub/uncuf W/mur Eye	Rusch, Inc.	BTR	Class II	1993-06-22
K931111	Endopath Disposable Flexible Surgical Cannula	Ethicon Endo-Surgery Inc	GCJ	Class II	1993-06-22
K930933	Endopath Endoscopic Surgical Instruments	Ethicon, Inc	GCJ	Class II	1993-06-22
K930685	Technicon H* 3Tm Rtc System (in-Vitro Diag.syst.)	Kulzer GmbH	GKL	Class II	1993-06-22
K930543	E-25 Krypton Ion Laser (Surgica K5)	Hgm, Inc.	GEX	Class II	1993-06-22
K930493	Quantum 3080 Surgical Table	American Sterilizer Co.	FQO	Class I	1993-06-22
K930471	Sherwood Medical Arterial Blood Gas Kit II	Sherwood Medical Co.	CBT	Class I	1993-06-22
K930351	Narkomed 2C Anesthesia System	Draeger, Inc.	BSZ	Class II	1993-06-22
K930299	Bard(r) Blood Cardioplegia Heat Exchanger/tube Set	C.R. Bard Inc	DTN	Class II	1993-06-22
K930286	Dri-Vendt/provent/accuvent Arterial Blood Gas Kits	Concord/Portex	CBT	Class I	1993-06-22
K930147	Surgical Mesh Delivery System, General Surgery	Davol, Inc.	GCJ	Class II	1993-06-22
K930049	Infrared Exposure Hand Switch	Mid X-Ray, Inc.	IZL	Class II	1993-06-22
K926513	Moller-Wedel Operating Microscope	Moeller Microsurgical, Inc.	FSO	Class I	1993-06-22
K926454	Anesthesia Respiratory Breath Circuit Packs/compon	Medical, Inc.	CAI	Class I	1993-06-22
K926226	Intersept Filtered Cardiotomy Reservoir	Medtronic, Inc.	DTZ	Class II	1993-06-22
K926201	Osteonics Microsutered Femoral Componentes	Osteonics Corp.	LPH	Class II	1993-06-22
K926138	Carpentier-Edwards Physio Annuloplasty Ring	Baxter Healthcare Corporation	KRH	Class II	1993-06-22
K925664	Series V-Scan Radiographic Film Scanner	Vision Ten, Inc.	LLZ	Class II	1993-06-22
K925639	Cardiomagic Software	Instromedix, Inc.	DXH	Class II	1993-06-22
K925484	Carbon Dioxide & Oxygen Monitor Type 1308	Bruel & Kjaer	CCK	Class II	1993-06-22
K925216	Sterile Skin Scrub Trays	American Healthcare Supply Co., Inc.	LRO	Class II	1993-06-22
K925099	Possis Medical Myopore Bipolar Sutureless Mycardia	Possis Medical, Inc.	DTB	Class III	1993-06-22
K924755	Convatec Little Ones Pediatric Urine Collection	Convatec, A Division of E.R. Squibb & Sons	EXI	Class I	1993-06-22
K924179	EEG Model 24/32	Lama Engineering, Inc.	GWQ	Class II	1993-06-22
K924051	Kit Pak i.v. Start Kit	Kit Pak, Inc.	LYY	Class I	1993-06-22
K923906	Foley Insertion Tray	Kit Pak, Inc.	KOD	Class II	1993-06-22
K923613	Synthes Limited Contact-Dynamic Hip Screw Implant	Synthes (USA) Products LLC	JDO	Class II	1993-06-22
K923089	Examination Gloves Powder Free	Glovoco (M) Sdn Bhd	LYY	Class I	1993-06-22
K921948	Synthes Universal Spine Hook and Rod Fixation Syst	Synthes (USA) Products LLC	KWP	Class II	1993-06-22
K921767	Compact Cotrel -- Dubousset Spine System	Buckman Co., Inc.	KWP	Class II	1993-06-22
K921443	Tip & Membrane Assembly	Bio-Rad	HKX	Class II	1993-06-22
K920620	Fluoro-Shield Radiation Reduction Gloves	Acufex Microsurgical, Inc.	LZC	Class I	1993-06-22
K915222	Walker Hip Prosthesis	Zimmer GmbH	LZO	Class II	1993-06-22