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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 489 of 3529

510(k) clearances, page 489 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K182845	minisono	ALPINION MEDICAL SYSTEMS Co., Ltd.	IYN	Class II	2018-12-27
K182564	Quantib ND	Quantib B.V.	LLZ	Class II	2018-12-27
K182461	LATITUDE EV Total Elbow Arthroplasty	TORNIER Inc.	JDB	Class II	2018-12-27
K182404	STERRAD VELOCITY Biological Indicator	Advanced Sterilization Products (Asp)	FRC	Class II	2018-12-27
K182130	iSchemaView RAPID	Ischemaview, Inc.	LLZ	Class II	2018-12-27
K182045	Lotus III Multi-Pulsed Er: Yag Laser System	Laseroptek	GEX	Class II	2018-12-27
K182783	DePuy Synthes Trauma Orthopedic Nail Implants	DePuy Synthes	HRS	Class II	2018-12-26
K182709	One-Step Suprapubic Introducer	Cook Incorporated	KOB	Class II	2018-12-26
K182698	LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device	Diasorin Inc.	NXO	Class II	2018-12-26
K182242	VO200 – NeurOs Cerebral Oximetry System	Mespere Lifesciences Inc.	QEM	Class II	2018-12-26
K182099	Delta TT Pro	Lima Corporate S.p.A.	LPH	Class II	2018-12-26
K181761	Zimmer Biomet Select Ceramic Heads	Zimmer GmbH	LZO	Class II	2018-12-26
K183007	EliA SmDP Immunoassay	Phadia AB	LKP	Class II	2018-12-24
K181641	QuikClot Radial	Z-Medica, LLC	QSY	Unclassified	2018-12-24
K183328	Pulse Rx 2.0, Pulse Pro Rx 2.0	Normatec Industries, LP	JOW	Class II	2018-12-21
K183068	Nitrile Glove Powder Free White	Haining Medical Products Co., Ltd.	LZA	Class I	2018-12-21
K183059	3nethra neo	Forus Health Pvt.ltd.	HKI	Class II	2018-12-21
K183012	vascuCAP	Elucid Bioimaging	LLZ	Class II	2018-12-21
K182795	LENSAR Laser System - fs 3D (LLS-fs 3D)	LENSAR, Inc	OOE	Class II	2018-12-21
K182781	PTS Professional Chemistry Kit	Polymer Technology Systems, Inc. D/B/A Pts Diagnostics	CGA	Class II	2018-12-21
K182776	Neocis Guidance System	Neocis Inc.	PLV	Class II	2018-12-21
K182755	Disposable Temperature Probe	Shenzhen Caremed Medical Technology Co.,Ltd.	FLL	Class II	2018-12-21
K182750	4D View	GE Healthcare	LLZ	Class II	2018-12-21
K182690	ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel	Genmark Diagnostics, Incorporated	PEO	Class II	2018-12-21
K182682	OrthoGold 100	Tissue Regeneration Technologies	ISA	Class I	2018-12-21
K182167	The ICHOR Panacea Vascular Embolectomy Catheter System	Ichor Vascular Inc	QEW	Class II	2018-12-21
K182032	SterilContainer S System	Aesculap Inc	KCT	Class II	2018-12-21
K182012	ADVIA Centaur Calcitonin (CALCT) assay	Axis-Shield Diagnostics, Ltd.	JKR	Class II	2018-12-21
K181752	Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)	Stryker Corp.	HRX	Class II	2018-12-21
K181690	Clear-Jet Injection Catheter	Finemedix	FBK	Class II	2018-12-21
K181555	Arthrex Fracture Adapter Hemi Shoulder Prosthesis	Arthrex GmbH	KWS	Class II	2018-12-21
K181412	Vitek Ms	bioMerieux, Inc.	QBN	Class II	2018-12-21
K181331	JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White	Juvora	EBI	Class II	2018-12-21
K181120	2.8 mm/3.3 mm PopLok Suture Anchors	ConMed Corporation	MBI	Class II	2018-12-21
K181037	DIO CAD/CAM Abutment	Dio Corporation	NHA	Class II	2018-12-21
K180826	Natrelle 133 Plus MICROCELL Tissue Expander	Allergan	LCJ	Unclassified	2018-12-21
K180821	TruMatch Graft Cage - Long Bone	Synthes (USA) Products LLC	HRS	Class II	2018-12-21
K180380	vital signs monitor	Edan Instruments, Inc.	DQA	Class II	2018-12-21
K180014	Creme de La Femme Feminine Lubricant	Cewal, Inc. dba Premiere Enterprises	NUC	Class II	2018-12-21
K173747	Rexlene	Sm Eng Co., Ltd.	GAW	Class II	2018-12-21
K173036	North-vision Multi-parameter Patient Monitor	North-Vision Tech., Inc.	MHX	Class II	2018-12-21
DEN180007	Miris Human Milk Analyzer	Miris AB	QEI	Class II	2018-12-21
DEN170070	MLL (KMT2A) Breakapart FISH Probe Kit; AML1 (RUNX1) Breakapart FISH Probe Kit, P53 (TP53) Deletion FISH Probe Kit; EVI1 (MECOM) Breakapart FISH Probe Kit, Del(20q) Deletion FISH Probe Kit; AML1/ETO (RUNX1/RUNXIT1)) Translocation, Dual Fusi, CBFB (CBFB) /MYH11 Translocation, Dual Fusion FISH Probe Kit,Del(5q)Deletion FISH Probe Kit; Del(7q)Deletion FISH Probe Kit	Cytocell Limited	QDI	Class II	2018-12-21
K183267	DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System	Osprey Medical, Inc.	DXT	Class II	2018-12-20
K183123	microTargeting Guideline 4000 5.0 System	FHC, Inc.	GZL	Class II	2018-12-20
K183115	MTS Levofloxacin 0.002 - 32 µg/mL	Liofilchem S.r.l.	JWY	Class II	2018-12-20
K183036	Dilator Sets	Cook Incorporated	DRE	Class II	2018-12-20
K182972	Phoenix Atherectomy System	Volcano Atheromed, Inc.	MCW	Class II	2018-12-20
K182670	FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute	Prosidyan, Inc.	MQV	Class II	2018-12-20
K182454	O2 Concepts Oxlife Independence Model 301-0001	O2 Concepts, LLC	CAW	Class II	2018-12-20