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 1822 of 3531

510(k) clearances, page 1822 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K980985	Scmd-1000	Howard Instruments, Inc.	HNO	Class I	1998-05-01
K980965	Spectra Form Chromatic Alginate Impression Material	Cavex Holland B.V.	ELW	Class II	1998-05-01
K980852	Gii Spinal Fixation System	Karen E. Warden, M.E.B.E.	MNH	Class II	1998-05-01
K980833	Immulite Pyrilinks-D Model Numbers Lkpd1, Lkpd5	Siemens Healthcare Diagnostics Inc.	JMM	Class I	1998-05-01
K980815	Endopath Ez45 Endoscopic Linear Cutter	Ethicon Endo-Surgery Inc	OCW	Class II	1998-05-01
K980683	Trovafloxacin 10G, Sensi-Disc	Becton Dickinson Microbiology Systems	JTN	Class II	1998-05-01
K980661	Cera E Dental Alloy	European Dental Imports, Inc.	EJS	Class II	1998-05-01
K980650	Rep Cholesterol Profile Template-30, -16, -8; Rep Vis Cholesterol	Helena Laboratories, Corp.	JHO	Class I	1998-05-01
K980640	Heelbo Waist and Chest Vest	Heelbo, Inc.	FMQ	Class I	1998-05-01
K980633	Endosolv E	Specialites Septodont	KIF	Class II	1998-05-01
K980598	Ebna-1 Igm Elisa Test System	Trinity Biotech USA	LLM	Class I	1998-05-01
K980510	Keratome Blade (135 Micron, Model 300135), (160 Micron, Model 300160), (200 Micron, Model 30020)	Micro Specialties, Inc.	HNO	Class I	1998-05-01
K980508	Keratome Blade, Chirom Model Alk 500500; Keratome Blade, S.c.m.d. Model Turokeratome 400400	Micro Specialties, Inc.	HNO	Class I	1998-05-01
K980393	Soprano Cryo-Therapy System	Gynecare Innovation Center	GEI	Class II	1998-05-01
K980385	Datascope 8Fr. Co-Lumen 34 and 40Cc Intra-Aortic Balloon Catheters for Optional Sheathless Insertion with Accessories	Datascope Corp.	DSP	Class II	1998-05-01
K980384	Trip Tonometry Catheter, 18F	Datex-Engstrom, Inc.	CCK	Class II	1998-05-01
K980206	Immulite Anti-Tg Ab	Siemens Healthcare Diagnostics Inc.	JZO	Class II	1998-05-01
K980096	Oac (Optical Aspirating Curette)	Imagyn Medical Technologies, Inc.	HCY	Class I	1998-05-01
K980046	Bronchial Catheter System	Broncus Technologies, Inc.	EOQ	Class II	1998-05-01
K974883	Bactec Mgit 960 System	BD Becton Dickinson Vacutainer Systems Preanalytic	MDB	Class I	1998-05-01
K974711	Coamatic Plasminogen	Instrumentation Laboratory Co.	GGP	Class II	1998-05-01
K974649	Bio-Post Dental Post System	Advanced Aeromedical, Inc.	ELR	Class I	1998-05-01
K974456	Cmvgen	Instrumentation Laboratory Co.	LJO	Class II	1998-05-01
K971994	B-D Assure Ear Thermometer	Becton Dickinson Consumer Products	FLL	Class II	1998-05-01
K963364	Glass Van Glass Syringes	Myco Medical Supplies Inc	FMF	Class II	1998-05-01
K981280	Cp 1000, Curix Ht 330, Classic E.o.s., Curix Ht 530, Mamoray Ht 300, Mamoray Cmpact Plus, Curix Compact Plus, Curix Coms	Bayer Corp., Agfa Div.	IXW	Class II	1998-04-30
K981023	Kleenaseptic	Metrex Research	LRJ	Class I	1998-04-30
K980922	Protec Cem.	Ivoclar North America, Inc.	EMA	Class II	1998-04-30
K980623	N Tech Double Puncture Laparoscope/n Tech Operating Laparoscope	N-Tech Endoscopy, Inc.	GCJ	Class II	1998-04-30
K980616	Permafix Chairside Soft Denture Relining (7010) (7011-13) (7014-15)	Kohler Medizintechnik GmbH & Co. KG	EBI	Class II	1998-04-30
K980568	Jumbo Glass Ionomer Cement	Centrix, Inc.	EMA	Class II	1998-04-30
K980534	Duran Flexible Annuloplasty Ring Model Number H608h	The Heart Valve Div. Medtronic Cardiovascular Surg	KRH	Class II	1998-04-30
K980483	Mentor Suspend Sling	Mentor	FTL	Class II	1998-04-30
K980443	Peak Flow Meter Minimax	D&T Inc.	BZH	Class II	1998-04-30
K980441	Spirometer Model Npb-500	Medtronic, Inc.	BZG	Class II	1998-04-30
K980437	Silicone Punctal Plug	Oasis Medical, Inc.	LZU	Unclassified	1998-04-30
K980400	Pvrs-Peregrine Vitreoretinal Scissor Model Pd505.10	Peregrine Surgical, LLC.	HQE	Class II	1998-04-30
K980399	Peregrine Optiport Vitrectomy Probe Model Pd500.20	Peregrine Surgical, LLC.	HQE	Class II	1998-04-30
K980383	Mooorldi Laser Doppler Imager	Moor Instruments Ltd.	DPT	Class II	1998-04-30
K974438	Medrad Atd-T Interface Device	Medrad, Inc.	MOS	Class II	1998-04-30
K973834	Cs2000 & Cs2000 Tomo	Pausch Corp.	IZF	Class II	1998-04-30
K973741	Bair Hugger Blood/fluid Warmer	Augustine Medical, Inc.	BSB	Class II	1998-04-30
K973335	Quatro Sp Sample Processing Systems (200-499, Inclusive)	Zenyx Scientific, Ltd.	JQW	Class I	1998-04-30
K973170	Sis Wound Dressing	Cook Biotech, Inc.	KGN	Unclassified	1998-04-30
K972705	Resheather Device-Metal or Plastic, Resheater/ Needle Holder Device-Plastic	Sage Products LLC	FMI	Class II	1998-04-30
K972419	Toennies Neuroscreen System	Erich Jaeger, Inc.	IKN	Class II	1998-04-30
K971377	Greatbatch Scientific Mr Compatible Laryngoscope	Wilson Greatbatch Technologies, Inc.	CCW	Class I	1998-04-30
K970460	Nellcor Puritan Bennett, 840 Ventilator System (Model 840)	Medtronic, Inc.	CBK	Class II	1998-04-30
K970211	Microlife Automatic Blood Pressure Monitor	Micro Weiss Electronics	DPW	Class II	1998-04-30
K970139	Microlife Manual Blood Pressure Monitor (Manual Inflate) Model Bp-2Bio	Micro Weiss Electronics	DPW	Class II	1998-04-30