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 3351 of 3526

510(k) clearances, page 3351 of 3526
K number	Device	Applicant	Product code	Class	Decision date
K801127	Macrovac	Progress Mankind Technology	JOL	Class II	1980-05-30
K801109	Proof (Biological/chemical Indicator)	Amsco Co.	JOJ	Class II	1980-05-30
K801108	Double Ended Vented Transfer Device	Burron Medical Products, Inc.	FMI	Class II	1980-05-30
K801107	Double Ended Filtered Transfer Needle	Burron Medical Products, Inc.	FMI	Class II	1980-05-30
K801099	Unicuf, Blood Pressure Cuff	Frontier Products	DXQ	Class II	1980-05-30
K801034	Tanning Booth/tans by Tanique	Dawa Enterprises, Inc.			1980-05-30
K801025	Odor Masking Agent for Contents of All	The Buckeye Cellulose Corp.	FYA	Class II	1980-05-30
K801016	Gambro G Series Blood Line Sets for Hem.	Gambro, Inc.	FJK	Class II	1980-05-30
K800955	Tube Feeding Container 1500 Ml Dispose.	The Healthcare Group Laboratories, Inc.	KNT	Class II	1980-05-30
K800947	Midstream Collection Kit	Sage Products LLC	FMH	Class I	1980-05-30
K800915	Johnloz Endoscopy Handle	Endoscopic Surgical Accessories, Inc.	KNS	Class II	1980-05-30
K800896	Wolff System	Wolff System GmbH	LEJ	Class II	1980-05-30
K800864	Sterile Dispos. Plastic Stopcocks W/tube	Custom Medical Devices Intl., Inc.	FMG	Class II	1980-05-30
K800863	Tandem Assembed 3&4 Way Sterile Stopcks	Custom Medical Devices Intl., Inc.	FMG	Class II	1980-05-30
K800862	1,3 & 4 Way Sterile Dis. Plastic Pkg.	Custom Medical Devices Intl., Inc.	FMG	Class II	1980-05-30
K800844	Medebar Xl	Medefield Pty., Ltd.	KTA	Unclassified	1980-05-30
K800842	Medebar Xac-90	Medefield Pty., Ltd.	KTA	Unclassified	1980-05-30
K800841	Medebar M	Medefield Pty., Ltd.	KTA	Unclassified	1980-05-30
K800839	Medescan	Medefield Pty., Ltd.	KTA	Unclassified	1980-05-30
K800826	Fibrinogen Screen	Pacific Hemostasis	KQJ	Class II	1980-05-30
K800694	Mmg Disposable Urinary Leg Bag	Medical Marketing Group	KNX	Class II	1980-05-30
K800689	Reagent for Determ. Glutamic-Pyruvic-	Diagnostic Solutions, Inc.	CKA	Class I	1980-05-30
K800681	Reagents for Determ. CO2 in Human Serum	Diagnostic Solutions, Inc.	KMS	Class II	1980-05-30
K800656	A-Gent Quantichrom Thrombigen-E	Abbott Medical	GGQ	Class II	1980-05-30
K800459	Barium Sulfate, Usp in Suspension	Central Pharmaceuticals, Inc.	KTA	Unclassified	1980-05-30
K800354	Lead, Tined Pacing, Implantable	Daig Corp.	DTB	Class III	1980-05-30
K791328	Aller-Screen Skin Test Kit	Aller-Screen, Inc.	SCL	Class II	1980-05-30
K801216	Den-Mat Dentin Bonding Agent	Den-Mat Corp.	KLE	Class II	1980-05-28
K801213	Concept Endotracheal Tube	Concept, Inc.	BTR	Class II	1980-05-28
K801208	Hollow Basket Titanium Dental Implant	Colmed, Ltd.	ELE	Class II	1980-05-28
K801196	Libco Sunglasses	Libco Eyewear, Inc.	HQY	Class I	1980-05-28
K801191	Anesthesia Breathing Circuits	Airlife, Inc.	CAI	Class I	1980-05-28
K801176	Fiber Optic Light Source	Aspen Laboratories, Inc.	EQH	Class I	1980-05-28
K801173	Angio-Flo Monitoring Kit	Hospital Products Co.	KRA	Class II	1980-05-28
K801130	Ames Tda Amikacin	Miles Laboratories, Inc.	KLQ	Class II	1980-05-28
K801115	Dahlberg Hearing Aid Model Mel	Dahlberg Electronics, Inc.	ESD	Class I	1980-05-28
K801114	Dahlberg Hearing Aid Model Meh	Dahlberg Electronics, Inc.	ESD	Class I	1980-05-28
K801103	Compalor-Dental Model	Narco Mckesson Co.	BSZ	Class II	1980-05-28
K801100	Analor Four-Dental Model	Narco Mckesson Co.	BSZ	Class II	1980-05-28
K801089	J.t. Baker Nephelometer	J.T. Baker Chemical Co.	JQX	Class I	1980-05-28
K801086	P-Nitrophenyl Phosphate	Macomb Chemical Co.			1980-05-28
K801083	Normcap Cd-102, Carbon Dioxide Analyzer	Instrumentarium-Datex	CCL	Class II	1980-05-28
K801067	Telesonic, Generic & Soundex C-102	Telesonic, Inc.	ESD	Class I	1980-05-28
K801066	Telesonic, Soundex & Generic V-101	Telesonic, Inc.	ESD	Class I	1980-05-28
K801058	Illuminated Speculum	Designs for Vision, Inc.	FXF	Class I	1980-05-28
K801037	Centria System 2 Automated Method/ria	Union Carbide Corp.	LCI	Class I	1980-05-28
K801030	Riause Auto Processor	Electro-Nucleonics Laboratories, Inc.	JQW	Class I	1980-05-28
K801029	Clinical Data System (Cam) Module	Philips North America LLC	LEJ	Class II	1980-05-28
K801027	Mds Imager	Medtronic, Inc.			1980-05-28
K801026	Il Model 773 Fluorescence Light Scatter	Instrumentation Laboratory Co.	JJG	Class I	1980-05-28