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 1954 of 3531

510(k) clearances, page 1954 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K963460	Roll Belt	Skil-Care Corp.	FMQ	Class I	1996-10-09
K963457	Sleeper Jacket/houdini Safety Sleeper	Skil-Care Corp.	FMQ	Class I	1996-10-09
K963237	Heelbo ICU 911 Blazer Sleeved Jacket	Heelbo, Inc.	FMQ	Class I	1996-10-09
K963108	Heelbo Quilted Torso Restraint	Hollister, Inc.	FMQ	Class I	1996-10-09
K963084	Opus Cmv Test System-Modification	Behring Diagnostics, Inc.	LFZ	Class II	1996-10-09
K962921	Bard a-Trac Urological Balloon Dilation Catheter	C.R. Bard Inc	EZN	Class II	1996-10-09
K962886	Anesthesia Conduction Needle	Ispg, Inc.	BSP	Class II	1996-10-09
K962810	Great Hands Mitts	Heelbo, Inc.	FMQ	Class I	1996-10-09
K962778	The L-Bow Arm Restraint	Heelbo, Inc.	FMQ	Class I	1996-10-09
K962707	Minntech Minnifilter Plus Hemofilter and Tubing Set	Medivators Inc	KDI	Class II	1996-10-09
K962006	Menicon Z (Tisilfocon a) Rigid Gas Permeable Contact Lens	Menicon Co. Ltd.	HQD	Class II	1996-10-09
K961841	Bard V-Max Roller Bar (3551Xx;xx=01,02,03,04,05, or 06)	C.R. Bard Inc	FAS	Class II	1996-10-09
K963681	Cca-100 (Modified)	Benson Medical Instruments Co.	EWO	Class II	1996-10-08
K963644	A-1000 EEG Monitor and a-1050 EEG Monitor	Aspect Medical Systems, Inc.	OLW	Class II	1996-10-08
K963499	Mirror Finish Bipolar Forceps	Johnson & Johnson Professionals, Inc.	GEI	Class II	1996-10-08
K963456	Limb Holders-Reusable/limb Holders-Disposable/quick-Cuff Limb Holder	Skil-Care Corp.	FMQ	Class I	1996-10-08
K963455	Sleeved Jacket/sleeved Jacket with Slider Control	Skil-Care Corp.	KID	Class I	1996-10-08
K963253	Synthetic Absorbable Surgical Suture	United States Surgical, A Division of Tyco Healthc	GAM	Class II	1996-10-08
K963123	Arthrocare Arthroscopic Eletrosurgery System (Model 980)	ArthroCare Corporation	GEI	Class II	1996-10-08
K962966	Ids Rapid Cb Plus System	Innovative Diagnostic Systems, Inc.	JTO	Class I	1996-10-08
K962941	Oolitt Tongue Cleaner, Regular Low Ripple/special High Ripple/low Ripple Double/high & Low Ripple/comfort Eze	Deep Trading Corp.	LCN	Class I	1996-10-08
K962803	Apex Finder Models 7005	Sybron Dental Specialties, Inc.	LQY	Unclassified	1996-10-08
K962497	Q-Tips, Faichney, Private Label	Faichney Medical Co.	FLL	Class II	1996-10-08
K962464	Scantibodies Laboratory Tsh Immunoradiometric Assay (Irma)(coated Tube Technology)	Scantibodies Laboratory Inc.	JLW	Class II	1996-10-08
K962098	Esophageal Intubation Detector	Kirk Specialty Systems	BTR	Class II	1996-10-08
K962042	Glass Syringe	Ispg, Inc.	FMF	Class II	1996-10-08
K961769	Air-Medex I	Robert Gold Assoc.	FNM	Class II	1996-10-08
K961647	Deroyal Industries, Inc. Electrosurgical Cautery Pencil	DeRoyal Industries, Inc.	GEI	Class II	1996-10-08
K961590	Apex Universal Irrigation System & Two-Connection Tubing Set	Linvatec Corporation	HRX	Class II	1996-10-08
K961463	Heartport Thoracic Surgical Trocars: (Tost-4-3, Tostl-6-3, Ton-4-2 and Tonl-6-2	Heartport, Inc.	GCJ	Class II	1996-10-08
K961401	Hp Cathstation - Model M1264b	Hewlett-Packard Co.	DPS	Class II	1996-10-08
K961378	Delta Hip Prosthesis	Zimmer GmbH	LWJ	Class II	1996-10-08
K960991	Etest Submission for Amoxicillin	Ab Biodisk	JWY	Class II	1996-10-08
K960918	Vidamed Tuna (Transurethral Needle Ablation) System	Vidamed, Inc.	GEI	Class II	1996-10-08
K955891	Cardioview Transtelephonic Software	Micromedical, Inc.	DPS	Class II	1996-10-08
K955877	Zimmer Zirconia Ceramic Femoral Head	Zimmer GmbH	LZO	Class II	1996-10-08
K955715	Cell Dyn 3500 Multi-Parameter Automated Hematology Analyzer (Modification)	Abbott Medical	GKZ	Class II	1996-10-08
K955520	Rescue Breather	International Safety, Inc.	CBP	Class II	1996-10-08
K954658	Perneczky Clip Applier/remover	Von Zeppelin GmbH	HCI	Class II	1996-10-08
K954584	Racz Epidural Catheter	Medic Evaluation Devices & Instruments Corp.	BSO	Class II	1996-10-08
K946127	Ohmeda Excel Draw-Over Military Vaporizer System	GE Healthcare	BSZ	Class II	1996-10-08
K963583	Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and Preattached Needle	West Pharma. Services IL, Ltd.	LHI	Class II	1996-10-07
K963551	Bio-Csf Liquid Control Level 1 and 2	Biocell Laboratories, Inc.	JJX	Class I	1996-10-07
K963454	Cushion Belt/cushion Slider Belt/adjusta-Loop Cushion Belt/quick Release Cushion Belt	Skil-Care Corp.	FMQ	Class I	1996-10-07
K963450	Safety Vest/shoulder Strap Vest/economy Safety Vest	Skil-Care Corp.	FMQ	Class I	1996-10-07
K963449	Pelvic Holder	Skil-Care Corp.	FMQ	Class I	1996-10-07
K963448	Econo Belt	Skil-Care Corp.	FMQ	Class I	1996-10-07
K963447	Double Support Poncho/slider Poncho	Skil-Care Corp.	FMQ	Class I	1996-10-07
K963427	Immage Immunochemistry System Transferrin (Trf) Reagent	Beckman Instruments, Inc.	DDG	Class II	1996-10-07
K963311	Team Etch	Centrix, Inc.	EBF	Class II	1996-10-07