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 1796 of 3531

510(k) clearances, page 1796 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K982511	Depuy Motech Moss Miami Spinal Systems	Depuy, Inc.	KWP	Class II	1998-09-14
K982483	Depuy Motech Peak Fixation System	Depuy Orthopaedics Inc.	HRS	Class II	1998-09-14
K982462	Fiber Optic Endoillumination Probe	Microvision, Inc.	FFS	Class II	1998-09-14
K982408	Aerotee, Model # 1001	Piper Medical Products	CAF	Class II	1998-09-14
K982396	Visivox, Model V-2	Rsq, LLC	LEZ	Unclassified	1998-09-14
K982390	Concise Compression Hip Screw System (Sterile)	Wrightmedicaltechnologyinc	KTW	Class II	1998-09-14
K982388	Surgi Stim	Vision Quest Industries, Inc.	IPF	Class II	1998-09-14
K982320	Depuy Motech Moss Miami Spinal System	Depuy, Inc.	KWP	Class II	1998-09-14
K982191	Chemical Cure Composite with Enamel Bond	Medental Intl.	EBF	Class II	1998-09-14
K982169	Sherlock Threaded Suture Anchor (Tin Coated)	Doctor'S Research Group, Inc.	MBI	Class II	1998-09-14
K982146	Pictools Medical Tool Kit Model 1.0	Pegasus Imaging Corp.	LLZ	Class II	1998-09-14
K981570	Aaron 1200 High Frequency Electrosurgical Generator, Model A1200 Aaron 1200 High Frequency Electrosurgical Generator Mod	Apyx Medical Corporation	GEI	Class II	1998-09-14
K981143	Dilkes Laser/suction Cannulae	Exmoor Plastics Limited	GEX	Class II	1998-09-14
K980662	Lichen, Bacterial in Line Breathing Filter	Dhd Healthcare Corp.	CAH	Class II	1998-09-14
K980566	Vaxess Peripherally Inserted Central Catheter	Boston Scientific Corporation	FOZ	Class II	1998-09-14
K972382	Ub Analyzer Ua-2, Reagent Kit and Bilirubin Control	Arrows Co., Ltd.	CIG	Class II	1998-09-14
K982894	Mic-Key Glow Profile Gastrostomy Replacement Kit	Ballard Medical Products	KNT	Class II	1998-09-11
K982744	Disposable Hand Switching Pencil, Push Button, 2 Piece with and without Holster, Models Sb 312Pb, Sb 312 Pbh	New Deantronics Taiwan Ltd.	GEI	Class II	1998-09-11
K982529	Randox Direct Ldl Cholesterol	Randox Laboratories, Limited	MRR	Class I	1998-09-11
K982331	Keller Pulse Oximeter, Model 850+	Keller Medical Specialties Products, Inc.	DQA	Class II	1998-09-11
K982216	Ultima Respiratory Effort Sensor Models 0520 and 0522	Braebon Medical Corp.	BZQ	Class II	1998-09-11
K982103	Ulmer (Vng) Video Nystagmograph	Synapsys, Inc.	GWN	Class II	1998-09-11
K982083	Acs Hi-Torque Balance Heavyweight Guide Wire with Hydrocoat Hydrophilic Coating	Boston Scientific Corporation	DQX	Class II	1998-09-11
K980908	Lactate Pro System	Kdk Corp.	KHP	Class I	1998-09-11
K980696	Foam Tip Injector	Staar Surgical AG	MSS	Class I	1998-09-11
K980578	Innerdyne Radially Expanding Vascular Access System (Heparin Coated)	Innerdyne, Inc.	DYB	Class II	1998-09-11
K983034	Cynosure Co3 Er:yag Laser	Cynosure, LLC	GEX	Class II	1998-09-10
K982702	Ventrix Subdural Tunneling Pressure Monitoring Kit Model Nl950-Sd	Camino Neurocare, Inc.	GWM	Class II	1998-09-10
K982589	Surgeon's Glove	Shiva Medicare, Ltd.	KGO	Class I	1998-09-10
K982557	Bard Proforma and Apollo Pre-Curved Papillotomes	Bard Interventional Products Div.	KNS	Class II	1998-09-10
K982397	Ves 3001-M Complete Video Endoscopic System	Angiolaz, Inc.	FWF	Class I	1998-09-10
K982254	Cobe Sentry Smarxt 43 Micron Arterial Filter with Primegard	LivaNova USA, Inc.	DTM	Class II	1998-09-10
K982223	Capiox Sx Hardshell Resevoir	Terumo Medical Corp.	DTN	Class II	1998-09-10
K982149	Smith & Nephew Dyonics Microlaparoscope	Smith & Nephew, Inc.	HET	Class II	1998-09-10
K982120	Digital Imaging System, Models Digitrex-1000 and Digitrex-2000 (Digitrex-X000 Family)	Trex Medical Corp.	LLZ	Class II	1998-09-10
K981344	Uresil Percutaneous Drainage Catheters with Hydrophilic Coating	Uresil, LLC	LJE	Unclassified	1998-09-10
K981334	Laparo CO2-Pneu (and with Video Monitoring)	Richard Wolf Medical Instruments Corp.	HIF	Class II	1998-09-10
K980869	Synox Sx 53-Bp, Sx 60-Bp, Sx 45-Jbp, Sx 53-Jbp , Models 120 444, 119 684, 120 438 and 120 143	BIOTRONIK AG	DTB	Class III	1998-09-10
K974188	Cetylcide-G	Kellerandheckman	MED	Class II	1998-09-10
K982929	Maxair Nasal Dilator System	Hnl Technologies	LWF	Class I	1998-09-09
K982735	Light Saber Bone Biopsy Needle	Minrad, Inc.	KNW	Class II	1998-09-09
K982669	Oxoid Streptomycin Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1998-09-09
K982528	Nafcillin Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1998-09-09
K982526	Sparfloxacin Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1998-09-09
K982524	Amoxicillin/clavulanic Acid Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1998-09-09
K982523	Sulfisoxazole Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1998-09-09
K982520	Cefonicid Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1998-09-09
K982519	Levofloxacin Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1998-09-09
K982517	Cefprozil Antimicrobial Susceptibility Test Disc	Oxoid, Ltd.	JTN	Class II	1998-09-09
K980429	Hp M2600a Viridia Telemetry System (Formerly Known as the Hp 2600A Omni-Care Telemetry System)	Hewlett-Packard Co.	DSI	Class II	1998-09-09