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 1764 of 3531

510(k) clearances, page 1764 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K983702	Modification to Abuscreen Online for Benzoidiazepines	Roche Diagnostic Systems, Inc.	JXM	Class II	1999-02-11
K982373	Uni-Gold Strep a Test Kit	Trinity Biotech, PLC	GTY	Class I	1999-02-11
K982003	Ds30 Hcy Homocysteine Assay Kit	Drew Scientific, Ltd.	LPS	Class II	1999-02-11
K990300	Suprashield Express Sterilization Wrap	Medtronic, Inc.	FRG	Class II	1999-02-10
K990127	Corflo Cubby Low Profile Gastrostomy Device (Lpgd)	Halyard Health	KNT	Class II	1999-02-10
K990088	Synthofil Nonabsorbable Pet Surgical Suture	Aesculap Inc	GAT	Class II	1999-02-10
K984413	Bionect Hydrogel	Fidia Pharmaceutical Corp.	MGQ	Unclassified	1999-02-10
K984276	Disposable Electrosurgery Grounding Pad	E & M Engineering, Inc.	GEI	Class II	1999-02-10
K984267	Modification of Bionect Hydrogel Foam	Fidia Pharmaceutical Corp.	MGQ	Unclassified	1999-02-10
K984266	Modification of Bionect Hydrogel Spray	Fidia Pharmaceutical Corp.	MGQ	Unclassified	1999-02-10
K984264	Modification of Bionect Clear Hydrogel	Fidia Pharmaceutical Corp.	MGQ	Unclassified	1999-02-10
K984262	Modification of Bionect Hydrogel Gauze Pads	Fidia Pharmaceutical Corp.	MGQ	Unclassified	1999-02-10
K984239	Slicktip Solid Laparoscopic Electrode, Models Lh01z, Lb02z, Ln03z, Lc04z, Ls05z, Ll06z, Lj07z	Apyx Medical Corporation	GEI	Class II	1999-02-10
K984236	Aaron Esu Foot-Control Adapter #A1205a	Apyx Medical Corporation	GEI	Class II	1999-02-10
K984117	Innova Telescopic Distractor	Innova Corp.	MQN	Class II	1999-02-10
K984030	Vipersoft	Integra Medical	EHD	Class II	1999-02-10
K984025	Care TENS	Care Rehab, Inc.	GZJ	Class II	1999-02-10
K983704	Modification to Abuscreen Online for Phencyclidine	Roche Diagnostic Systems, Inc.	JCM	Class II	1999-02-10
K983400	Auto Suture Site Marker Clip	United States Surgical, A Division of Tyco Healthc	GDW	Class II	1999-02-10
K983054	Medlite Q-Switched Nd:yag Laser, Medlite IV Q-Switched Nd: Yag Laser	Continuum Biomedical, Inc.	GEX	Class II	1999-02-10
K974426	Potency Test Strips, Indicator Test Strips	Reprocessing Products Corp	LIF	Class II	1999-02-10
K990226	Ge Logiq700 Diagnostic Ultrasound System with B-Flow	GE Healthcare	IYO	Class II	1999-02-09
K990104	Medtronic Model 7495 Extension Kit	Medtronic, Inc.	GZB	Class II	1999-02-09
K990027	Omnicorder, Model 464	Del Mar Avionics	DSH	Class II	1999-02-09
K984638	Paragon Bolus Accessory Set	Halyard Health	FPA	Class II	1999-02-09
K984610	Powder Free Nitrile Examination Gloves	Shiva Medicare, Ltd.	LZA	Class I	1999-02-09
K984609	Adec Dental Unit, Models Century Plus & Cascade, Dci Dental Unit, Model Series III	Lite Specialty Metal Works, Inc.	EIA	Class I	1999-02-09
K984556	Scican Classic	Schoelly Fiberoptic, GmbH	EIA	Class I	1999-02-09
K984461	Pre-Powder Vinyl Patient Examination Gloves	Shanghai Huamao Gloves Co., Ltd.	LYZ	Class I	1999-02-09
K984460	Powder-Free Vinyl Patient Examination Gloves	Shanghai Huamao Gloves Co., Ltd.	LYZ	Class I	1999-02-09
K984311	Nbr4 Mils Nitrile Powder Free Examination Gloves Non-Sterile	Sumirubber Industries (Kedah) Sdn. Bhd.	LZA	Class I	1999-02-09
K984146	Paragon Infusion	Halyard Health	FPA	Class II	1999-02-09
K984144	System U3 for Amoxicillin/clavulanic Acid	Ab Biodisk	JWY	Class II	1999-02-09
K984142	Sonicator Plus 992, Model Number Me 992 and Sonicator Plus 994, Model Number Me 994	Mettler Electronics Corp	IPF	Class II	1999-02-09
K984128	Enigma Denture Teeth	Davis Schottlander & Davis, Ltd.	ELM	Class II	1999-02-09
K984125	Powdered Latex Examination Gloves, Non-Sterile	Kilang Barangan Getah Dioh	LYY	Class I	1999-02-09
K984114	Sys Stim 294, Model Me 294	Mettler Electronics Corp	IPF	Class II	1999-02-09
K984097	Dc-Core	S & C Polymer GmbH	EBF	Class II	1999-02-09
K984063	Paragon Basal/bolus Administration Set	Halyard Health	FPA	Class II	1999-02-09
K983430	Lite-Touch Syringe	Medicore Co. Ltd.	FMF	Class II	1999-02-09
K983411	Colorvees IV Set 20 Drops/ml 105, 60 Drops/ml 105, Vented 20 Drops 105, Vented 60 Drops 105	Valnet Medical Corp.	FPA	Class II	1999-02-09
K983106	1St Impression	Den-Mat Corp.	ELW	Class II	1999-02-09
K982151	Steritite Process Indicator Accessories	Case Medical, Inc.	JOJ	Class II	1999-02-09
K981862	Resin 4	Harry J. Bosworth Co.	EBI	Class II	1999-02-09
K981679	Tcm 3000 and Tcm Endo	Nouvag AG	EFB	Class I	1999-02-09
K973289	Re Nu	Pacific Rim Dental, Inc.	EJR	Class I	1999-02-09
K990085	Millennium Mlc -120	Varian Assoc., Inc.	IYE	Class II	1999-02-08
K990071	Imagefusion 2.0	Radionics, Inc.	MUJ	Class II	1999-02-08
K990025	Careside Amylase	Careside, Inc.	JFJ	Class II	1999-02-08
K984588	Phased Array Flexible Cardiac Coil	Philips North America LLC	MOS	Class II	1999-02-08