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 2026-10-22, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 2890 of 3529

510(k) clearances, page 2890 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K862297	The D & C Pad-Sac	Nu-Gyn-Tek, Inc.	HCY	Class I	1986-07-07
K862271	Laurier Safety Long Sanitary Napkin (Modification)	Kao Corp.	HHD	Class I	1986-07-07
K862270	Laurier Overnight Sanitary Napkin (Modification)	Kao Corp.	HHD	Class I	1986-07-07
K862192	Resuscitator Models 10400/10500/10600/10700/10800	U.O. Equipment Co.	BTL	Class II	1986-07-07
K862180	Modified Cotropin Radioimmunoassay Kit	Clinetics Corp.	CEP	Class I	1986-07-07
K862003	Circuit Anes. Breathing & Components	Vital Signs, Inc.	CAI	Class I	1986-07-07
K861962	Vanilmandelic Acid (Vma) Reagent Set	Sterling Diagnostics, Inc.	CDF	Class I	1986-07-07
K861773	Zygotek Microcomputerized Semen Analysis System	Zygotek Systems, Inc.	DGB	Class I	1986-07-07
K861756	V-Trend Qc Urine Chemistry Controls Level, I & II	Texas Immunology, Inc.	JJW	Class I	1986-07-07
K861741	Tdx Rea Lactic Acid	Abbott Medical	KHP	Class I	1986-07-07
K861556	Modified Fetal Monitor Model Fm-2	Advantage Medical Systems, Inc.	HGM	Class II	1986-07-07
K861378	Ultramed Tf 122 Ultrason Vascu Imag & Doppler Syst	Ultramed, Inc.	JOP	Class II	1986-07-07
K861212	Direct Acu-Slide Test	Cal-Tech Diagnostics, Inc.	JHJ	Class II	1986-07-07
K860974	Model 545-45 Laser for Derma., Pod., Surgical	Britt Corp., Inc.	GEX	Class II	1986-07-07
K860123	5.0 Mhz Intraoperative Array	Siemens Medical Solutions USA, Inc.	IYO	Class II	1986-07-07
K862417	Nickel,20% Chromium Porcelain Fused to Metal Alloy	Austenal Dental, Inc.	EJH	Class II	1986-07-03
K862400	Biotis Kv Laked Blood Agar	Otisville Biotech, Inc.	JSJ	Class I	1986-07-03
K862399	Biotis Sxt Agar	Otisville Biotech, Inc.	JSJ	Class I	1986-07-03
K862398	Biotis Decarboxylase Media, Ornithine	Otisville Biotech, Inc.	JSF	Class I	1986-07-03
K862397	Biotis Decarboxylase Media, Lysine	Otisville Biotech, Inc.	JSF	Class I	1986-07-03
K862396	Biotis Decarboxylase Media, Arginine	Otisville Biotech, Inc.	JSF	Class I	1986-07-03
K862395	Biotis Decarboxylase Media, Base	Otisville Biotech, Inc.	JSH	Class I	1986-07-03
K862394	Biotis Mitis Salivarius	Otisville Biotech, Inc.	JSI	Class I	1986-07-03
K862393	Biotis Litmus Milk	Otisville Biotech, Inc.	JSE	Class I	1986-07-03
K862392	Biotis Motility Test Medium	Otisville Biotech, Inc.	JSF	Class I	1986-07-03
K862391	Biotis Desoxycholate Agar	Otisville Biotech, Inc.	JSI	Class I	1986-07-03
K862390	Biotis Bordet Gengou Agar	Otisville Biotech, Inc.	KZI	Class I	1986-07-03
K862389	Biotis Acetamide Agar	Otisville Biotech, Inc.	JSI	Class I	1986-07-03
K862388	Biotis Tcbs Agar	Otisville Biotech, Inc.	JSI	Class I	1986-07-03
K862387	Biotis Haemophilus Identification Quad	Otisville Biotech, Inc.	JSH	Class I	1986-07-03
K862368	Amplified Elisa Ige Kit	Allertec, Inc.	DGC	Class II	1986-07-03
K862264	English Plaintain Allergen Disc	Immuno Nuclear Corp.	DHB	Class II	1986-07-03
K862173	Perennial Rye Allergen Disc	Immuno Nuclear Corp.	DHB	Class II	1986-07-03
K862052	Model 438-01 Cardifix Implantable Pacing Lead	Intermedics, Inc.	DTB	Class III	1986-07-03
K862039	Concord Care Tray	Concord Laboratories, Inc.			1986-07-03
K862011	Multi-Day Electrodes	Medical Electronic Assn.	GXY	Class II	1986-07-03
K862008	Mono-Latex (Tm) Slide Test	Armkel, LLC	KTN	Class II	1986-07-03
K861451	Empi Model 720 Nms, TENS	Empi	GZJ	Class II	1986-07-03
K861376	Combison R 320A	Cone Instruments, Inc.	IYO	Class II	1986-07-03
K861228	7.5 Mhz Linear Probe (Ultrasonic Transducer)	General Electric Co.	ITX	Class II	1986-07-03
K860574	Gen-Probe Mycoplasma Pneumonia Rapid Detect System	Hologic, Inc.	LQG	Class I	1986-07-03
K860472	Nuclear Laser Alignment System for Cardic Stress	Nuclear Diagnostics, Inc.	IWE	Class I	1986-07-03
K855232	Somatosensory Evoked Potential Stimulator	Neuroscience, Inc.	GWF	Class II	1986-07-03
K862425	Macconkey Agar W/mug, Dri-Form and Pre-Form	Gibco Laboratories Life Technologies, Inc.	JSI	Class I	1986-07-02
K862348	Single-Use Patient Underpad	Procter & Gamble Mfg. Co.	KME	Class I	1986-07-02
K862276	Model 435-02 Cardifix Implantable Pacing Lead	Intermedics, Inc.	DTB	Class III	1986-07-02
K862083	Hygeia Sciences Urine Hcg Flow Thorugh Assay	Hygeia Sciences	JHJ	Class II	1986-07-02
K861918	V-Trend Eia Tsh	V-Tech, Inc.	JLW	Class II	1986-07-02
K861778	Clinifacts 200 Data Management System	Miles Laboratories, Inc.	JQP	Class I	1986-07-02
K861303	Glucometer II Improved Reflectance Photometer	Miles Laboratories, Inc.	CGA	Class II	1986-07-02