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 2026-10-15, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3066 of 3528

510(k) clearances, page 3066 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K841631	Model 3014 Suction Unit	Forma Scientific, Inc.	HHI	Class II	1984-07-03
K841355	Right Angled Pick	Treace Medical, Inc.	JYT	Class I	1984-07-03
K841327	Dental Cotton Rolls	Intl. Verbandstoff-Fabrik Schaffhau	EFN	Class I	1984-07-03
K841105	Multichannel 2000 Fluoroptic Thermomet	Luxtron	FLL	Class II	1984-07-03
K840271	Cementless Hip Prosthesis	Mecron Medical Products, Inc.			1984-07-03
K842457	Phadexact Serum, Allergen Specific Ige	Pharmacia, Inc.	DHB	Class II	1984-07-02
K842451	Rim Strep Kit	Austin Biological Laboratories	JSE	Class I	1984-07-02
K842424	Biotis Ld-Presumpto Quadrant Plate	Otisville Biotech, Inc.	JSE	Class I	1984-07-02
K842400	Biotis N.y.c. Carbohydrate Fermenta-	Otisville Biotech, Inc.			1984-07-02
K842383	Patho Dx Latex Agglutination Strep a	Siemens Healthcare Diagnostics Inc.	GTZ	Class I	1984-07-02
K842239	Ventrescreen Strep a Test	Ventrex Laboratories, Inc.	GWC	Class I	1984-07-02
K842070	Idd Detergent	Interscience Diagnostics, Inc.	PPM	Class I	1984-07-02
K842069	Idl-Lysing Reagent	Interscience Diagnostics, Inc.	GGK	Class I	1984-07-02
K842068	Idi Isotonic Diluent	Interscience Diagnostics, Inc.	GIF	Class I	1984-07-02
K841995	10.5 French Dilator, 15Cm, W/luer Lock	Quinton, Inc.	DRE	Class II	1984-07-02
K841484	Sterile o.r. Basin Kit Product Line	MEDLINE INDUSTRIES, LP - Northfield	FRG	Class II	1984-07-02
K841465	General Diagnostics Platelet Antibody	General Diagnostics	LLG	Class II	1984-07-02
K841077	Ark Tongue Cleaner	Arkay Co.	LCN	Class I	1984-07-02
K840795	Acs Sof-T Guide Wiree	Advanced Cardiovascular Systems, Inc.	DQT	Class II	1984-07-02
K840622	Cardio Express 100 Holter Scanner	Del Mar Avionics	DSI	Class II	1984-07-02
K842423	Para Therm Bath	Grimm Scientific Industries, Inc.	IMC	Class II	1984-06-28
K842380	Pressure Relief Seat Cushion	American Pharmaseal Div. Ahsc	KIC	Class I	1984-06-28
K842294	Dialysate Additives	Dialysis Products, Inc.	FKQ	Class II	1984-06-28
K842262	Pird-Y	Pirdy, Inc.	ISB	Class II	1984-06-28
K842075	Critikon i.v. Filter	Critikon Company, LLC	FPB	Class II	1984-06-28
K841716	Endoport Erocar	Endotherapeutics	FBQ	Class II	1984-06-28
K841704	Thinwall Puncture Needle	Meadox Surgimed, Inc.	FMI	Class II	1984-06-28
K841687	Skyndex Electronic Body Fat Calcula	Caldwell, Justiss & Co., Inc.	KTZ	Class I	1984-06-28
K841679	Vascular-Access-Port Withdrawl-Blood	Norfolk Medical Products, Inc.	LJT	Class II	1984-06-28
K841487	Intravascular Catheter Securement Dev	LTS Therapy Systems, LLC	KMK	Class I	1984-06-28
K840934	Medilog Ph1	Oxford Medilog, Inc.	EXW	Class II	1984-06-28
K840877	Argyle Enternal Feeding Bag W/admin	Sherwood Medical Co.	HFS	Class I	1984-06-28
K842512	Exacta-Film	Ardent Intl., Inc.			1984-06-27
K842287	Montgomery Laryngeal Stent	Boston Medical Products, Inc.	FWN	Class II	1984-06-27
K841998	Imr-90-Diploid-Human Fetal Lung Cell	Bartels Immunodiagnostic Supplies, Inc.	KIR	Class I	1984-06-27
K841675	Floss N' Gloss/safety Floss Med Device	Leonard Lorch	JES	Class I	1984-06-27
K841638	Aline Orthodontic Archwire	A Company, Inc.	DZC	Class I	1984-06-27
K841567	Audiometer Ma728	Maico Hearing Instruments, Inc.	EWO	Class II	1984-06-27
K841490	Polysulfide Custom Tray Material	Buffalo Dental Mfg Co Inc	ELW	Class II	1984-06-27
K841436	Oticon E28a	Oticon, Inc.	ESD	Class I	1984-06-27
K841323	Fuzzy Tray	Buffalo Dental Mfg Co Inc	EHY	Class I	1984-06-27
K841290	Steldent - Dental Alloy	Eriez	EJH	Class II	1984-06-27
K841252	Glattelast Compression Panty Hose	Baurs Krey Assoc., Inc.	DWL	Class II	1984-06-27
K841167	Demlar Sys I Computer Based Audiometer	Demlar Medical, Inc.	EWO	Class II	1984-06-27
K840726	Restodent Dentin Bonding Agent	Lee Pharmaceuticals	KLE	Class II	1984-06-27
K840172	Ventral Wall Defect Reduct Silo	American Heyer Schulte	FTL	Class II	1984-06-27
K833128	Forma-Fas-Test	Chemical Detection & Experimentation	LIF	Class II	1984-06-27
K842412	Model 4000 Md-Yag Laser for Malignant	Cooper Lasersonics, Inc.	HQF	Class II	1984-06-26
K842389	Avatron Disposable I.p.p.b. Cirucit	Avatron, Inc.	BZO	Class I	1984-06-26
K842372	Spiromate as-500	Riko Medical & Scientific Instrument Corp.	BZG	Class II	1984-06-26