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 2711 of 3530

510(k) clearances, page 2711 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K883200	Canon Autorefractometer R-22	Canon Medical Components U.S.A., Inc.	HKO	Class I	1988-08-18
K883185	Safecrit Plastic Microhematocrit Tubes	Norfolk Scientific, Inc.	GHY	Class II	1988-08-18
K883098	Site Sterilization Trays for Ophthalmic Use	Site Microsurgical Systems, Inc.	LRP	Class I	1988-08-18
K882959	Endovaginal Probe, Sms-510Va	Toshiba Medical Systems	IYO	Class II	1988-08-18
K880773	The Venus System	Neuroscientific Corp.	GWL	Class II	1988-08-18
K883061	Ats Para-Set Carbol-Xylene Solution	Alpha-Tech Systems, Inc.	JTS	Class I	1988-08-17
K883049	Ats Para-Set Iodine Alcohol Solution	Alpha-Tec Systems, Inc.	JTS	Class I	1988-08-17
K883048	Ats Para-Set Modified Pva Fixative Solution	Alpha-Tec Systems, Inc.	LDZ	Class I	1988-08-17
K882944	Dimertest(r) Latex	Agen Biomedical, Ltd.	DAP	Class II	1988-08-17
K882912	Sceptor New Antimicrobial Agent: Imipenem	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-08-17
K882911	Sceptor Exten. of Concentration Range: Pencillin	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-08-17
K882910	Sceptor New Antimicrobial Agent: Ampicillin/sulbac	BD Becton Dickinson Vacutainer Systems Preanalytic	JWY	Class II	1988-08-17
K882802	Storz Disposable Bipolar Pencils	Storz Instrument Co.	GXI	Class II	1988-08-17
K882212	Slt Contact Laser System	Surgical Laser Technologies, Inc.	GEX	Class II	1988-08-17
K881999	Platelin(r) Excel L	bioMerieux, Inc.	GIT	Class II	1988-08-17
K883312	L-F/kodak Flexible Grid Cassette	Mallinckrodt Group, Inc.	IXA	Class II	1988-08-16
K882930	Laser Laryngoscope Dedo Articula. & Feder Dedo Ex	Pilling Co.	CCW	Class I	1988-08-16
K882285	Nonrebreathing Circuit	Dryden Corp.	BTM	Class II	1988-08-16
K882229	Air Bed & Flotation Dermagard 800 & 900 Systems	Biologics Intl., Inc.	IOQ	Class II	1988-08-16
K882223	Pleur-Evac-a-7000--Adult/pedi Chest Drainage Syst	Deknatel, Inc.	KDQ	Class II	1988-08-16
K875027	Star Calc	Infrasonics Corp.	BZC	Class II	1988-08-16
K883292	Bovine Serum, Cat. Lno. 110-1115	J R Scientific	KIT	Class I	1988-08-15
K883291	Donor Horse Serum, Cat. No. 110-1110	J R Scientific	KIT	Class I	1988-08-15
K883290	Donor Bovine Serum, Cat. No. 110-1116	J R Scientific	KIT	Class I	1988-08-15
K883289	Calf Serum, Heat Inactivated, Cat. # 110-1127	J R Scientific	KIT	Class I	1988-08-15
K883288	Donor Horse Serum, Heat Inactivated, #110-1113	J R Scientific	KIT	Class I	1988-08-15
K883287	Calf Serum, Gamma Irradiated, Cat. No. 110-1126	J R Scientific	KIT	Class I	1988-08-15
K883286	Newborn Calf Serum, Heat Inactivated # 110-1131	J R Scientific	KIT	Class I	1988-08-15
K883285	Fetal Bovine Serum, Cat. No. 110-1120	J R Scientific	KIT	Class I	1988-08-15
K883141	Rpmi-1640 W/25mm Hepes Buff W/o Sod Bicar 200-2120	J R Scientific	KIT	Class I	1988-08-15
K883140	Minimum Essential Med (Mem,thermo-Pow(r)#200-2090	J R Scientific	KIT	Class I	1988-08-15
K883139	Medium 199 Ebss/nutrient Mixture F-10 #200-2110	J R Scientific	KIT	Class I	1988-08-15
K883138	Cmrl 1969 Maintenance Medium Cat, # 200-2177	J R Scientific	KIT	Class I	1988-08-15
K883075	Fastidious Inoculum Broth	Baxter Healthcare Corporation	JSD	Class I	1988-08-15
K882817	Lung Diffusion Gas Mixture	Swisco, Inc.	BYK	Class II	1988-08-15
K882694	Fixation Device, Trach Tube	Bioseal	CBH	Class I	1988-08-15
K882581	CT Max 640 #B7940 Ja/je	General Electric Co.	JAK	Class II	1988-08-15
K882488	Cantrol Hdl Cholesterol Precipi. Reag. and Tubes	Canyon Diagnostics, Inc.	LBR	Class I	1988-08-15
K882266	Digital EMG Monitor Myotron 120	Ats Co.	HCC	Class II	1988-08-15
K882022	Tomoscan Lx Computed Tomography System	Philips North America LLC	JAK	Class II	1988-08-15
K881207	Res-Q 1, 2, 3, 4 and 5	Nova-Ventrx	BTM	Class II	1988-08-15
K881002	O.r. Saracap	Ppg/Applied Resources, Inc.	CCK	Class II	1988-08-15
K880525	3 Phase High Freq. Diag. X-Ray Gen. Micro-X 60Hf	Fischer Imaging Corp.	IZO	Class I	1988-08-15
K883036	Palliag Nf III	Degussa Dental, Inc.	EJT	Class II	1988-08-12
K882960	Ids Rapid Ana System	Innovative Diagnostic Systems, Inc.	JSP	Class I	1988-08-12
K882915	Fortify	Bisco, Inc.	EBF	Class II	1988-08-12
K882828	Dental Floss Pick	Bik Pik	JES	Class I	1988-08-12
K882810	Easy-Op, Portable Dental Cart	Wy'east Medical Corp.	EIA	Class I	1988-08-12
K882805	Cilco Villasenor Pachymeter	Coopervision-Cilco	IYO	Class II	1988-08-12
K882759	Professional Model 7525 Delivery System	Viadent	EFS	Class I	1988-08-12