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 2026-10-21, 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 3007 of 3529

510(k) clearances, page 3007 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K850716	Selenite F Broth	Rapid City Regional Hospital, Inc.	JSJ	Class I	1985-03-22
K850715	Mueller Hinton Agar	Rapid City Regional Hospital, Inc.	JTZ	Class II	1985-03-22
K850676	Surgi-Pap Kit	Surgipath Medical Industries, Inc.	HHT	Class II	1985-03-22
K850579	Cue Fertility Monitor	Zetek, Inc.	NGE	Class I	1985-03-22
K850421	Cine Radiographic Film Processor M-45Cr	The Allen Products Co.	IXX	Class II	1985-03-22
K850302	Suplex & Suplex Diluent	Pro-Lab, Inc.	JSK	Class I	1985-03-22
K850266	American Pharmaseal Sterile i.v. Start Kit	American Pharmaseal Div. Ahsc			1985-03-22
K850197	Keller Cephalometric Device	Gary D. Keller	IWY	Class I	1985-03-22
K844928	Quanticel Hhr Two Human Hematology Reference	Bhp Diagnostix, Inc.	JPK	Class II	1985-03-22
K844927	Quanticel Hhr + Two Human Hematology W/platelets	Bhp Diagnostix, Inc.	JPK	Class II	1985-03-22
K844897	Hematology Control Uni-Cell 5, Uni-Cell 7 & 8	Medical Specialties Laboratories	JPK	Class II	1985-03-22
K842878	Gst System Thermographic Application	Gst Laboratories of Ca, Inc.	LHQ	Class I	1985-03-22
K851008	Electric Lift Table-Ophthalmic	Turbine Support Systems, Inc.			1985-03-21
K850962	Ophthalmic Dropper Bottles	Acacia, Inc.			1985-03-21
K850882	Acth II by Radioimmunoassay	Immuno Nuclear Corp.	CKG	Class II	1985-03-21
K850811	Pad, Pre-Operative Preparation	East Texas Lighthouse for the Blind	KME	Class I	1985-03-21
K850680	Encore Ferritin Reagent	Hybritech, Inc.	JMB	Class II	1985-03-21
K850644	Nasopharyngeal Airway-Robertazzi	Dryden Corp.	BTQ	Class I	1985-03-21
K850625	Argyle 15Mm Swivel Connector	Sherwood Medical Co.	BZA	Class I	1985-03-21
K850533	Atlantic Optical Systems Optifilter System	Atlantic Optical Systems, Inc.	FPA	Class II	1985-03-21
K850488	Stratofuse Syringe Piggyback Pump 1030	Strato Medical Corp.	FRN	Class II	1985-03-21
K850384	Ccs Implantable Maestro Series 100-Heart Pacemaker	Cardiac Control Systems, Inc.	DXY	Class III	1985-03-21
K850158	Chlamydia Fluoro-Kit 1680	Clinical Sciences, Inc.	LJP	Class I	1985-03-21
K850123	In-Th-Ear Hearing Aid	General Hearing Instruments, Inc.	ESD	Class I	1985-03-21
K850105	Km Products Aspirating Tubing	Km Products	BSY	Class I	1985-03-21
K845032	Phadebas Rast/phadezym Rast Allergen Discs	Pharmacia, Inc.	DHB	Class II	1985-03-21
K844736	Isis	Oxford Medilog, Inc.	LDK	Unclassified	1985-03-21
K844624	Basis Digital Thermometer Model Btm-1	Terayco Intl., Ltd.	FLL	Class II	1985-03-21
K844615	Biosampler	Biotek-Caribbean	CBT	Class I	1985-03-21
K844567	Titertek Twinreader 78-630-00	Flow Laboratories, Inc.	JJQ	Class I	1985-03-21
K844512	Dart Daily Air Removal Test	American Sterilizer Co.	JOJ	Class II	1985-03-21
K844419	Titertek Multiskan Mss/340	Flow Laboratories, Inc.	JJQ	Class I	1985-03-21
K844418	Titertek Multiskan Mcc	Flow Laboratories, Inc.	JJQ	Class I	1985-03-21
K844130	Acufex Arthroscopic Shaver	Acufex Microsurgical, Inc.	HSZ	Class I	1985-03-21
K842356	Custom Sterile Procedure Kits	Sterile Design, Inc.			1985-03-21
K850923	Bun (Rate) Reagent	Sigma Diagnostics, Inc.	CDQ	Class II	1985-03-20
K850905	Cr-39 Type Resin	Orplex Corp.	HQG	Class I	1985-03-20
K850902	Data Zyme Acid Phosphatase Procedure	Data Medical Associates, Inc.	CKB	Class II	1985-03-20
K850883	Scleral Sponge II, Olk Design, E5395-10 & E5395-11	Storz Instrument Co.	HOZ	Class II	1985-03-20
K850848	Brain Heart Infusion Agar	Micro Media Laboratories	JSG	Class I	1985-03-20
K850847	Thioglycolate Medium W/vitamin Kl & Hemin	Micro Media Laboratories	JSG	Class I	1985-03-20
K850846	Salt Broth	Micro Media Laboratories	JSJ	Class I	1985-03-20
K850845	0.85% Saline	Micro Media Laboratories	PPM	Class I	1985-03-20
K850844	V Agar	Micro Media Laboratories	JSH	Class I	1985-03-20
K850843	Mueller Hinton Chocolate Agar	Micro Media Laboratories	JTZ	Class II	1985-03-20
K850842	Brain Heart Infusion Broth	Micro Media Laboratories	JSG	Class I	1985-03-20
K850841	Mod Thayer Martin Martin Lewis	Micro Media Laboratories	JTY	Class II	1985-03-20
K850756	Auto-D Automatic Disinfection Access/attachments	Travenol Laboratories, S.A.	FKR	Class II	1985-03-20
K850738	Supplement for Culture Medium	Roseville Medical Laboratoriesu	JSK	Class I	1985-03-20
K850737	Transport Culture Medium	Roseville Medical Laboratoriesu	PPM	Class I	1985-03-20