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 2794 of 3530

510(k) clearances, page 2794 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K873142	Personna Disposable Scalpel	American Safety Razor Co.	GES	Class I	1987-09-04
K873135	Unifast Gamma-Gt	Sclavo, Inc.	JQB	Class I	1987-09-04
K873099	Manual Ophthalmic Surgical Instruments	Alcon Laboratories	HNF	Class I	1987-09-04
K873097	Procedual Changes/assembly Process for Plus Paks	Ipax, Inc.	GBQ	Class I	1987-09-04
K873044	Porex Otology Instruments	Porex Medical	LRC	Class I	1987-09-04
K873001	Hearing Aid (All-in-the-Ear)	Littlefield Co.	ESD	Class I	1987-09-04
K872944	Look Spring-Assist Syringes	Look, Inc.	FMF	Class II	1987-09-04
K872941	Spectro C	Ramco Laboratories, Inc.	GGP	Class II	1987-09-04
K872905	American Nasal Sponge	American Silk Sutures, Inc.	EPP	Class I	1987-09-04
K872875	Stretch Gauze Bandages	Abco Dealers, Inc.	NAD	Class I	1987-09-04
K872855	18Mm Peyman Wide Field Yag Laser Lens	Ocular Instruments, Inc.	HJK	Class II	1987-09-04
K872832	Trach Collar	Rotek Corp.	CBH	Class I	1987-09-04
K872831	Biotrol Alpha Amylase	Biotrol, USA, Inc.	CIJ	Class II	1987-09-04
K872826	Ultra-Neb 99 Ultrasonic Nebulizer	The Devilbiss Co.	CAF	Class II	1987-09-04
K872820	Safety Syringe	BD Becton Dickinson Vacutainer Systems Preanalytic	FMF	Class II	1987-09-04
K872802	Trokel Single Mirror Yag Laser Lens	Ocular Instruments, Inc.	LQJ	Class II	1987-09-04
K872795	Change in Sterility Test Method & Test Lab. Site	Medex, Inc.	FPA	Class II	1987-09-04
K872759	Aquatulle Fine Mesh Non-Adhering Dressing	Smith & Nephew, Inc.	EFQ	Unclassified	1987-09-04
K872747	Laser Centering Device	Innomed, Inc.	HMR	Class I	1987-09-04
K872590	Solcotrans Chest Drainage Autotransfusion System	Solco Basle, Inc.	CAC	Class II	1987-09-04
K872544	Irrigation Pressure Monitor	Avec Scientific Design Corp.	HRX	Class II	1987-09-04
K872531	Mic Mushroom Tip Gastrostomy Tube	Medical Innovations, Inc.	KNT	Class II	1987-09-04
K872371	Icor Neonatal Hch	Icor AB	BYD	Class I	1987-09-04
K872327	Whirlpool Aerator Wb700, Wb800, Wb900, Wb975	Associated Mills, Inc.	ILJ	Class II	1987-09-04
K872233	Inject-Ease	Palco Laboratories, Inc.	KZH	Class II	1987-09-04
K872228	Pharmaseal Alternating Pressure Pad System	American Pharmaseal Div. Ahsc	FNM	Class II	1987-09-04
K871965	Jms Needles and Jms Syringes	JMS Co., Ltd.	FMF	Class II	1987-09-04
K871802	Model K210 and K211 Fluidotherapy Units	Henley Intl.	LSB	Class II	1987-09-04
K870801	Flo-Gard 6200 Volumetric Infusion/pumping Blood	Travenol Laboratories, S.A.	FRN	Class II	1987-09-04
K863387	Multiple	Del Mar Avionics	DXK	Class II	1987-09-04
K863136	High Profile Needle Electrode (N-Spyral Hp)	Neurotechnics, Inc.	GXZ	Class II	1987-09-04
K863135	Low Profile Needle Electrode (N-Spyral Lp)	Neurotechnics, Inc.	GXZ	Class II	1987-09-04
K872750	Lake Catheter Care Kit	Lake Medical Products, Inc.	KOD	Class II	1987-09-03
K872394	Sonopuls 464, Ultrasound Therapy Equipment	Henley Intl.	IMG	Class II	1987-09-03
K872278	Siemens O2-Air Mixer 965	Siemens Elema AB	BZR	Class II	1987-09-03
K872170	Crt Portable Emergency Oxygen Inhalator	Cost Reduction Technologies, Inc.	CAN	Class I	1987-09-03
K873310	Abbott Spectrum(r) Liquid Creatinine Reagent	Abbott Medical	CGX	Class II	1987-09-02
K873180	Biotrol Magnesium Calmagite	Biotrol, USA, Inc.	JGJ	Class I	1987-09-02
K873118	Biotrol Reference	Biotrol, USA, Inc.	JIX	Class II	1987-09-02
K873116	Multi Analyte Mixtures, Calibrators	Biotrol, USA, Inc.	JIX	Class II	1987-09-02
K873067	Acromed Bone Screw Tap Sleeves	Buckman Co., Inc.	HWX	Class I	1987-09-02
K873066	Acromed Screw Driver	Buckman Co., Inc.	HXX	Class I	1987-09-02
K872803	Cyberfluor 615 Immunoanalyzer	Cyberfluor, Inc.	KHO	Class I	1987-09-02
K872789	Paramax Urine/csf Calibrator	American Dade	JIX	Class II	1987-09-02
K872390	Allegro(tm) Human Chorionic Gonadotropin Im System	Nichols Institute Diagnostics	JHI	Class II	1987-09-02
K871903	Quick Qualitative Calcium Test (Quick-Cal)	Creative Scientific Technology, Inc.	JFN	Class II	1987-09-02
K871328	Du Pont Legionella Urinary Antigen - Ria Kit	E.I. Dupont de Nemours & Co., Inc.	LHL	Class II	1987-09-02
K873005	Techmedica Heavyd Gauge Titanium Mesh Sheet/strips	Techmedica, Inc.	HRS	Class II	1987-09-01
K872755	Karyotec 100	Amcor Electronics, Ltd.	LNJ	Class II	1987-09-01
K872705	Bovie 400-CT Electrosurgical Generator (Unit)	Clinical Technology Inc.	GEI	Class II	1987-09-01