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 2198 of 3531

510(k) clearances, page 2198 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K941734	Phonak Sono-Forte 331X Bte Hearing Instruments	Phonak, Inc.	ESD	Class I	1994-05-13
K941626	Gridgil	Gilardoni S.p.A.	IXJ	Class I	1994-05-13
K941611	Tda-4000/A4	Toshiba America Medical Systems, In.C	JAA	Class II	1994-05-13
K935915	Wet Sense	Edson Corp.	KPN	Class II	1994-05-13
K934722	Prism 3000 Nuclear Gamma Camera System Modification	Ohio Imaging, Inc.	KPS	Class II	1994-05-13
K934638	Reusable Cw Doppler Probes: Models P8m05s8a, P8m05n5a, & Lcw-8	Koven Technology, Inc.	JOP	Class II	1994-05-13
K934426	Nerve Integrity Monitor-2 (Nim-2 Xl)	Xomed-Treace, Inc.	ETN	Class II	1994-05-13
K934317	Cidba Corning Acs Cortisol Immunoassay	Ciba Corning Diagnostics Corp.	JFT	Class II	1994-05-13
K933747	Capasee	Toshiba America Medical Systems, In.C	IYO	Class II	1994-05-13
K932269	Pro-Connect	Starkey Laboratories, Inc.	ESD	Class I	1994-05-13
K941955	Lorex Tracheostomy Gauze Sponges - Sterile 1'S and 2'S	Lorrex Health Products	EFQ	Unclassified	1994-05-12
K941694	Isl Qc 2000 Laser	Intelligent Surgical Lasers, Inc.	GEX	Class II	1994-05-12
K941528	Pearl Packing Forceps	Cook Incorporated	HCZ	Class II	1994-05-12
K941522	Sterile X-Ray Detectable Gauze Sponges	Cush Medical Products	GDY	Class I	1994-05-12
K941471	Central Line Dressing Change Tray	Clinical Resources, Inc.	FRG	Class II	1994-05-12
K941469	IV Start Kit	Clinical Resources, Inc.	LRS	Class II	1994-05-12
K941468	Debridement Tray, Incision and Drainage Tray	Clinical Resources, Inc.	FRG	Class II	1994-05-12
K941467	Wound Dressing Kit	Clinical Resources, Inc.	FRG	Class II	1994-05-12
K941344	Lap Sponge Product Line	Cush Medical Products	GDY	Class I	1994-05-12
K941302	Sterile Impervious Orthopedic Stockinette	Cush Industries, Inc.	KKX	Class II	1994-05-12
K941294	Sharp II Low Profile Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1994-05-12
K941293	Sharp II Semi Contour Hearing Aid	Miracle-Ear, Inc.	ESD	Class I	1994-05-12
K941292	Sharp II Full Contour	Miracle-Ear, Inc.	ESD	Class I	1994-05-12
K941229	Ontrac Steerable Guidewire	Lake Region Mfg., Inc.	DQX	Class II	1994-05-12
K941133	770-Atc	Electone, Inc.	ESD	Class I	1994-05-12
K941122	Audiotone Model a-54Sr	Miracle-Ear, Inc.	ESD	Class I	1994-05-12
K941121	Audiotone Model a-54	Miracle-Ear, Inc.	ESD	Class I	1994-05-12
K941039	Wax Guard Option	Miracle-Ear, Inc.	ESD	Class I	1994-05-12
K940814	Hydro-M(tm) Wound Gel	Kingston Technologies, Inc.	MGQ	Unclassified	1994-05-12
K940346	Scissors for Endoscopic and Laparoscopic Procedures	Karl Storz Endoscopy-America, Inc.	GCJ	Class II	1994-05-12
K940274	Nylon Liner Gloves	Wells Lamont Corp.	LYU	Class I	1994-05-12
K940036	Endosurg Disposable Secondary Trocar	Endosurg	DRC	Class II	1994-05-12
K936250	Retractors, Speculum, Clip Applier for Titanium Clips, 2-Way Stop Cock, Palpation Probe, Knot Guide, Roeder Loop	Medicon Instruments, Inc.	GCJ	Class II	1994-05-12
K936223	Pressure Irrigating System	Level 1 Technologies, Inc.	GCY	Class I	1994-05-12
K935986	Gore Laparoscopic Suture Passer	W. L. Gore & Associates, Inc.	GCJ	Class II	1994-05-12
K935724	The Expandacell Sinus Pack	Denver Splint Co.	EMX	Class I	1994-05-12
K935403	Wedge Pressure Balloon Catheter by J-Lloyd	J-Lloyd Medical, Inc.	DQO	Class II	1994-05-12
K934899	Bifurcated Lead Adaptors, 3.2Mm & 5.0 Mm	Telectronics Pacing Systems, Inc.	DTD	Class II	1994-05-12
K934865	Omnipulse Model 1210-Vhp Ho:yag Laser System	Trimedyne, Inc.	GEX	Class II	1994-05-12
K934541	Scimed 6 French Angiographic Catheter Modification	Scimed Life Systems, Inc.	DQO	Class II	1994-05-12
K933811	Morelle Sos Treatment, Morelle Mamaplast, Morelle Abdoplast	Pitt Enterprises (Silicone), Ltd.	MDA	Class I	1994-05-12
K933497	Laparoscopic Covered Surgical Retractor	Advanced Surgical, Inc.	GCJ	Class II	1994-05-12
K932924	Implex a-230 Porous Acetabular Cup Syst. Cemented	Implex Corp.	LPH	Class II	1994-05-12
K932803	Clestraclean(r) Room Air Purifier	Clestra Cleanroom Technology, Inc.	FRA	Class II	1994-05-12
K932553	Disposable Suture Placement System	Laurus Medical Corp.	GCJ	Class II	1994-05-12
K932502	Lonza Formulation R-82	Lonza, Inc.	LRJ	Class I	1994-05-12
K932277	Lonza Formulation R-82	Calgon Vestal Div.	LRJ	Class I	1994-05-12
K931697	Fixation Pin	Orthologic Corp.	HTY	Class II	1994-05-12
K930048	Safe-Picc Catheter	Menlo Care, Inc.	FOZ	Class II	1994-05-12
K941989	Action at Manual Wheelchair	Nvacare Corp.	IOR	Class I	1994-05-11