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 2026-10-08, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,902 of the 176,299 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	2,502

176,299 records, page 3364 of 3526

510(k) clearances, page 3364 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K800262	Perfringens Supplement a	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12
K800261	Dermasel Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12
K800260	Streptococcus Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12
K800259	Oxytetracycline Antibiotic Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12
K800258	Staphylococci/streptococci Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12
K800257	Campylobacter Selective Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12
K800256	Tinsdale Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12
K800255	Sterile Gc Supplement (W/o Antibiotics)	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12
K800254	Mycoplasma Supplement P	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12
K800253	Mycoplasma Supplement G	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12
K800252	Sterile Gc Supplement	Oxoid U.S.A., Inc.	JSK	Class I	1980-03-12
K800192	Duralite Lens	American Optical Corp.	HPX	Unclassified	1980-03-12
K800061	Bond Elut Columns	Analytichem International, Inc.	DJY	Class I	1980-03-12
K800029	Surgicot 2 Indicator System	Surgicot, Inc.	FRC	Class II	1980-03-12
K792349	Susceptibility Disk, Cinoxacin 100 Mcg.	Pfizer Inc	JNT	Class I	1980-03-12
K792252	Dms 3000	Renal Care Corp.	FKQ	Class II	1980-03-12
K800463	Esophageal Stethescope	Medical Components, Inc.	BZW	Class I	1980-03-10
K800443	Hygrotherm	JEDMED Instrument Company	ETP	Class I	1980-03-10
K800442	Variotherm	JEDMED Instrument Company	ETP	Class I	1980-03-10
K800397	Ellik Bladder Evacuator	Sage Products LLC	KQT	Class II	1980-03-10
K800367	Micresurgical Tray, Sm.,med., & Lg.	Edward Weck, Inc.	FSM	Class I	1980-03-10
K800365	Earscope	Nash & Assoc.	ERA	Class I	1980-03-10
K800363	Parke-Davis Total Knee Prosthesis	Warner-Lambert Co.	KTZ	Class I	1980-03-10
K800318	Doubletime 2-Tipped Appliers for Hemocli	Edward Weck, Inc.	HBT	Class I	1980-03-10
K800295	0.9% Sodium Chloride Sol./resp. Therapy	Abbott Medical	CAF	Class II	1980-03-10
K800294	0.45% Sodium Chloride Sol./resp. Therapy	Abbott Medical	CAF	Class II	1980-03-10
K800238	Moire Fringe Visometer After Lotmar	Hagg-Streit Service, Inc.	HKL	Class II	1980-03-10
K800225	Micronta Bp-1 Electronic B/p Tester	Tandy Corp.	DXN	Class II	1980-03-10
K800112	Amblyopia Trainer	Life-Tech Instruments, Inc.	HPL	Class I	1980-03-10
K792050	3M Small Volume Infustion (Svi) System	3M Company	FRN	Class II	1980-03-10
K800013	Fetal Monitor Model Fhm-1	Advantage Medical Systems, Inc.	HGM	Class II	1980-03-07
K800448	Water Pik Traveler, Model 79	Teledyne, Inc.	EFS	Class I	1980-03-05
K800444	Golden Retrievers or Silver Retrievers	Instrument Makar, Inc.	HXB	Class I	1980-03-05
K800332	Radioear Model 2080 (Hearing Aid)	Radioear Corp.	ESD	Class I	1980-03-05
K800331	Surgitek Foerster Face Lift Drain	Medical Engineering Corp.	GCY	Class I	1980-03-05
K800310	Ortho Antisera Control	Ortho Diagnostics, Inc.	KSF	Class II	1980-03-05
K800301	Sigma Procedure & Reagent System #335-UV	Sigma Chemical Co.	CDT	Class I	1980-03-05
K800300	Amerlex T-4 Ria Kit	Amersham Corp.	CDX	Class II	1980-03-05
K800297	Sandare Fast 340 Phosphorous Procedure	Sandare Chemical Co., Inc.	CEO	Class I	1980-03-05
K800296	Whole Blood Gas Control, Levels 1,2,&3	Dade, Baxter Travenol Diagnostics, Inc.	GGM	Class II	1980-03-05
K800282	Data Management System Il Model 775	Instrumentation Laboratory Co.	JQP	Class I	1980-03-05
K800114	Siemens-Elema Ab Manual Ventilation	Siemens Elema AB	CBK	Class II	1980-03-05
K800005	ECG Monitor Oscilloscope Model Oec-3100	Nihon Kohden America Inc	DPS	Class II	1980-03-05
K800004	ECG Monitor Oscilloscope Model Oec-3200	Nihon Kohden America Inc	DPS	Class II	1980-03-05
K792725	Fixomull	Beiersdorf, Inc.	FPX	Class I	1980-03-05
K800491	Graphic Stress Telethermometry	Gst Laboratories of Ca, Inc.	IYM	Class III	1980-03-04
K800372	Sanitary Napkins, Maxi 30'S	Giant Eagle Markets, Inc.	HHD	Class I	1980-03-03
K800334	Martin-Lewis Agar	Isle Media and Sterile Products, Inc.	JTY	Class II	1980-03-03
K800333	Modified Thayer-Martin X Agar	Isle Media and Sterile Products, Inc.	JTY	Class II	1980-03-03
K800329	Campylobacter Agar, Cat. No. P2536	Gibco Laboratories Life Technologies, Inc.	JSJ	Class I	1980-03-03