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 3378 of 3526

510(k) clearances, page 3378 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K792242	Surgi-Prep Paint Stick #1 Wet Pack	Gard Research Corp.	GEC	Class I	1979-12-10
K792215	Pentex Upper G.i. Scope Model Fg-28A	Pentax Precision Instrument Corp.	GCT	Class II	1979-12-10
K792207	Peridial Peritoneal Dialysis Tray	Cutter Laboratories, Inc.	FKG	Class I	1979-12-10
K792176	Drape, Microscope	Chris Co., Inc.	KKX	Class II	1979-12-10
K792169	Horizontal Radiographic 4/Way Floating	Bennett X-Ray Corp.	IZZ	Class II	1979-12-10
K792156	Lancer Specimen Container	Sherwood Medical Co.	FMH	Class I	1979-12-10
K792123	Kodak Lanex Med. Screen	Eastman Kodak Company	EAM	Class I	1979-12-10
K792067	Vtx (Ge Cataolg No. B7005a)	General Electric Co.	IZF	Class II	1979-12-10
K792429	Him Test Cocaine	Tecknam, Inc.	DLN	Class II	1979-12-07
K792417	Elvi Blood Urea Nitrogen	Volu Sol Medical Industries	CDL	Class II	1979-12-07
K792416	Elvi Total Proteins	Volu Sol Medical Industries	CER	Class II	1979-12-07
K792415	Elvi Total Bilirubin & Fractions	Volu Sol Medical Industries	CIG	Class II	1979-12-07
K792414	Elvi Triglyceride	Volu Sol Medical Industries	JGY	Class I	1979-12-07
K792413	Elvi Alkaline Phosphatatase	Volu Sol Medical Industries	CJE	Class II	1979-12-07
K792412	Elvi Uric Acid	Volu Sol Medical Industries	CDH	Class I	1979-12-07
K792406	Elvi Serum Iron	Volu Sol Medical Industries	CFM	Class I	1979-12-07
K792405	Elvi Acid & Prostatic Phosphatase	Volu Sol Medical Industries	JFH	Class II	1979-12-07
K792404	Elvi Creatinine	Volu Sol Medical Industries	CGX	Class II	1979-12-07
K792403	Elvi Uric Acid-Colorimetric Method	Volu Sol Medical Industries	CDH	Class I	1979-12-07
K792402	Elvi Creatinin	Volu Sol Medical Industries	CGX	Class II	1979-12-07
K792401	Elvi Inorganic Phosphorous	Volu Sol Medical Industries	CEO	Class I	1979-12-07
K792400	Elvi Chloride	Volu Sol Medical Industries	CHJ	Class II	1979-12-07
K792399	Elvi Magnesium	Volu Sol Medical Industries	JGJ	Class I	1979-12-07
K792398	Elvi Glucose	Volu Sol Medical Industries	CGA	Class II	1979-12-07
K792397	Elvi Creatinine	Volu Sol Medical Industries	CGX	Class II	1979-12-07
K792313	Chol-Hdl Test, High Lipo. Chol Test	Sclavo, Inc.	LBR	Class I	1979-12-07
K792235	Coagulase Plasma	Remel Co.	JTL	Class I	1979-12-07
K792034	Integral Disposable Holder Carpentier	Edwards Laboratories	DTJ	Class I	1979-12-07
K792020	Ae 840 Physiological Pressure Transducer	Life Medical Services, Inc.	DRS	Class II	1979-12-07
K791792	Sci Med Pericardial Substitute	Scimed Life Systems, Inc.	DXZ	Class II	1979-12-07
K792445	Mw Straight Attachment	Midwest	EGS	Class I	1979-12-06
K792411	Elvi Total Bilirubin & Fractions	Volu Sol Medical Industries	CIG	Class II	1979-12-06
K792410	Elvi Sgot & Sgpt Transaminase	Volu Sol Medical Industries	CIS	Class II	1979-12-06
K792409	Elvi Total Iron Binding Capacity	Volu Sol Medical Industries	JQF	Class I	1979-12-06
K792408	Elvi Albumin	Volu Sol Medical Industries	CIX	Class II	1979-12-06
K792396	Elvi Calcium	Volu Sol Medical Industries	CIA	Class II	1979-12-06
K792391	Cotton Roll Compression Caps	Parker Laboratories, Inc.	EFN	Class I	1979-12-06
K792384	Principal Analyte Reference Serum	Beckman Instruments, Inc.	JIX	Class II	1979-12-06
K792378	Hemospenser Cartridge Cat. No. 523500-	Edward Weck, Inc.	GDO	Class I	1979-12-06
K792376	Quantitative Control Urine II (Human)	Environmental Chemical Specialties	JJW	Class I	1979-12-06
K792375	Elevated Lipid Control	Environmental Chemical Specialties	JJY	Class I	1979-12-06
K792374	Quantitative Control Urine I (Human)	Environmental Chemical Specialties	JJW	Class I	1979-12-06
K792362	Blood Urea Nitrogen Reagent	Connecticut Diagnostics, Ltd.	JGZ	Class II	1979-12-06
K792352	Synthes Cervical Vertabrae Plates	DePuy Synthes	KWQ	Class II	1979-12-06
K792347	Micro Lowry Proteintest	Panmed, Inc.	JGP	Class II	1979-12-06
K792346	Two Minute Proteintest	Panmed, Inc.	CEK	Class II	1979-12-06
K792340	Connect. Diag. Total Protein Diag. Reage	Connecticut Diagnostics, Ltd.	CEK	Class II	1979-12-06
K792339	Connect. Diag. Albumin Diagnostic Reagen	Connecticut Diagnostics, Ltd.	CIX	Class II	1979-12-06
K792338	Donnect. Diag. Total Bilirubin Reagents	Connecticut Diagnostics, Ltd.	CIG	Class II	1979-12-06
K792337	Donnect. Diag. Calcium Diag. Reagent	Connecticut Diagnostics, Ltd.	CIC	Class II	1979-12-06