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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2797 of 3530

510(k) clearances, page 2797 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K872199	Dyno-Max II - Computerized Muscle Analyzer	Dyno-Max Co.	IKK	Class II	1987-08-21
K871614	Decub-I-Con 800 and 900 System	Wholesale Medical Supply, Inc.	IOQ	Class II	1987-08-21
K871467	Biopsy Needle Guide Kit, Sterile	Amedic USA	FCG	Class II	1987-08-21
K870367	Chloride Reagent - Thiocyanate Method	Trace Scientific, Ltd.	CHJ	Class II	1987-08-21
K870362	Calcium Reagent - Cresolphthalein Complexon Method	Trace Scientific, Ltd.	CIC	Class II	1987-08-21
K864911	Exersystem(tm) Mmc 5000	Med Science	BZM	Class II	1987-08-21
K873034	Controlchek Ii(tm)	Petra Biomedical Products, Inc.	JTO	Class I	1987-08-19
K873028	Minimum Essential Medium Eagle(mem Alpha Modifica)	J R Scientific	KIT	Class I	1987-08-19
K873027	Minimum Essential Medium Eagle (Mem)cat. #200-2045	J R Scientific	KIT	Class I	1987-08-19
K873026	Dulbecco's Modified Eagle's Medium (Dme)	J R Scientific	KIT	Class I	1987-08-19
K873025	Minimum Essential Medium Eagle(mem) Cat.#200-2115	J R Scientific	KIT	Class I	1987-08-19
K873024	Medium 199, Catalog No. 200-2030	J R Scientific	KIT	Class I	1987-08-19
K873023	Rpmi-1640 W/l-Glutamine and W/o Sodium Bicarbonate	J R Scientific	KIT	Class I	1987-08-19
K873022	Iscove's Modified Dulbecco's Medium (Imdm)	J R Scientific	KIT	Class I	1987-08-19
K873021	L-15 Medium, Cat. #200-2020	J R Scientific	KIT	Class I	1987-08-19
K873020	Minimum Essential Medium Eagle(mem) Cat.#200-2041	J R Scientific	KIT	Class I	1987-08-19
K873019	Minimum Essential Medium Eagle(mem), Cat.#200-2040	J R Scientific	KIT	Class I	1987-08-19
K873018	Dulbecco's Modified Eagle's Medium (Dme)	J R Scientific	KIT	Class I	1987-08-19
K873017	Dulbecco's Modified Eagle's Medium (Dme)	J R Scientific	KIT	Class I	1987-08-19
K873016	Mccoy's 5A Medium (Iwakata & Grace Modification)	J R Scientific	KIT	Class I	1987-08-19
K873015	Nutrient Mixture F-12 (Ham), Cat. #200-2065	J R Scientific	KIT	Class I	1987-08-19
K873014	Nutrient Mixture F-10 (Ham) Cat. # 200-2060	J R Scientific	KIT	Class I	1987-08-19
K873013	Minimum Essential Medium Eagle(mem Alpha Modifica)	J R Scientific	KIT	Class I	1987-08-19
K872484	Modified Enzymatic Bun Reagent	Trace Scientific, Ltd.	CDQ	Class II	1987-08-19
K872483	Modified Alt (Gpt) Reagent	Trace Scientific, Ltd.	CKA	Class I	1987-08-19
K872324	Lb 9502 - Clinilumat, Lb 952 - Auto-Clinilumat	Berthold Analytical Instruments, Inc.	JJQ	Class I	1987-08-19
K872148	Vivid Chlamydia(tm)	Seragen Diagnostics, Inc.	LJC	Class I	1987-08-19
K872129	Latex R. Conorii	Health Research, Inc.	LSQ	Class I	1987-08-19
K870372	Albumin Reagent - Bromcresol Green Method	Trace Scientific, Ltd.	CIX	Class II	1987-08-19
K870371	Total Protein Reagent - Biuret Method	Trace Scientific, Ltd.	CEK	Class II	1987-08-19
K870370	Magnesium Reagent - Calmagite Method	Trace Scientific, Ltd.	JGJ	Class I	1987-08-19
K870369	Calcium Reagent-Methyl Thymol Blue Method	Trace Scientific, Ltd.	CIA	Class II	1987-08-19
K870368	Phosphorus Reagent-Direct UV Method W/o Reduction	Trace Scientific, Ltd.	CEO	Class I	1987-08-19
K870366	Creatinine Reagent - Picric Acid Method	Trace Scientific, Ltd.	CGX	Class II	1987-08-19
K870365	Direct Bilirubin Reagent - Acid Diazo Method	Trace Scientific, Ltd.	CIG	Class II	1987-08-19
K870364	Total Bilirubin Reagent - Dmso Method	Trace Scientific, Ltd.	CIG	Class II	1987-08-19
K854654	Sm Part Servo Sec. Duplex Dop 7-5/5 9814-219-50007	Philips North America LLC	IYO	Class II	1987-08-19
K872306	System Pack for B.m.d/hitachi 704 Chem. Ana.(gaba)	Boehringer Mannheim Corp.	CIC	Class II	1987-08-18
K872025	Porocoat (R) Proximal Femoral Third Prosthesis	Depuy, Inc.	KWL	Class II	1987-08-18
K871996	Abbott Biotell Pregnancy Test	Abbott Medical	LCX	Class II	1987-08-18
K871570	Apex Alpha Vacuum Pump	Apex Medical, Inc.	BTA	Class II	1987-08-18
K871443	Casandra Syringe Cap	Casandra Medical Corp.	FMF	Class II	1987-08-18
K870947	Dynatron 500	Dynatronics Corp.	IPF	Class II	1987-08-18
K865098	Slimline Unipolar Endocardial Pacing Lead, 030-438	Telectronics, Inc.	DTB	Class III	1987-08-18
K873009	Concept Switching Stick	Concept, Inc.	KGZ	Class I	1987-08-17
K873002	Min-Identoflex	Centrix, Inc.	EHJ	Class I	1987-08-17
K872991	Micrins Forceps 2010	Micrins Surgical, Inc.	GEN	Class I	1987-08-17
K872990	Micrins Surgical Scissor	Micrins Surgical, Inc.	FZT	Class I	1987-08-17
K872912	Triglyceride (UV) Reagent	Sigma Chemical Co.	JGW	Class I	1987-08-17
K872859	Ace Cancellous Bone Screw	Ace Medical	HWC	Class II	1987-08-17