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 2793 of 3530

510(k) clearances, page 2793 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K870268	Diagnostic Kit Free T3 and Free T4	Sclavo, Inc.	CEC	Class II	1987-09-14
K873476	Mini-Motor Hand Engine & Access. Dermabrasion Burs	Mcghan Medical Corp.	GEY	Class I	1987-09-11
K873475	Micro-Torque Hand Engine & Access. Dermabra. Burs	Mcghan Medical Corp.	GEY	Class I	1987-09-11
K873439	Laceration Tray	Ulti-Med Intl., Inc.	LRP	Class I	1987-09-11
K873434	Creat Brand Malar Implant	Aesthetech Corp.	LZK	Class II	1987-09-11
K873391	Modified Round (Beehive) Dissector 3/8	Ormed Mfg., Inc.	GDY	Class I	1987-09-11
K873370	Allen Malleable Anesthesia Screen	Edgewater Medical Equipment Systems	FWZ	Class I	1987-09-11
K873358	Gemeni Uric Acid u.v.	Electro-Nucleonics Laboratories, Inc.	CDO	Class I	1987-09-11
K873345	'Microlyte 4/5'	Kone Instruments, Inc.	JFP	Class II	1987-09-11
K873304	Clinitek Auto 2000 Reagent Cassette (Leukocytes)	Miles Laboratories, Inc.	LJX	Class I	1987-09-11
K873143	Ros-Tr System	Ross Systems C/O Arent,Fox,Kintner,Plotkin,Kahn	DZE	Class II	1987-09-11
K872589	Accessory to Laser Equipment - Smoke Evacuator	Class, Inc.	GEX	Class II	1987-09-11
K872471	Titane Sl Dental Burr	Titane SL Co.	ECM	Class I	1987-09-11
K872444	Silux Plus Light Cured Restorative Material	3M Company	EBF	Class II	1987-09-11
K872315	Mistmaster	Sonora Respiratory Products, Inc.	CCQ	Class I	1987-09-11
K872301	Dentocult-Sm Culture-Paddle	Orion Corp.	JSI	Class I	1987-09-11
K872073	Bio-Interference Blanking Material, Am Cat. #2052	American Monitor Corp.	JIT	Class II	1987-09-11
K871785	Denture Cleansing Tablet	Pennex Products Co., Inc.	EFT	Class I	1987-09-11
K871615	U. V. Germicidal Unit	Lorvic Corp.	KMH	Class II	1987-09-11
K864457	Chlamyset Antibody Eia	Orion Corp.	LJC	Class I	1987-09-11
K873283	Model C2-5000 Overhead Tube Support	Transworld X-Ray Corp.	IYB	Class I	1987-09-10
K872913	Alleia Total Ige Irma W/mono. Anti. Rkie 1,2,5	Siemens Healthcare Diagnostics Inc.	DGC	Class II	1987-09-10
K872801	Alleia Total Ige Eia W/mono Anti. Ekie1, 2, 5	Siemens Healthcare Diagnostics Inc.	DGO	Class II	1987-09-10
K872106	Dantec Counterpoint	Dantec Electronics, Inc.	GWF	Class II	1987-09-10
K873348	Cell-Dyn Diff Screen, Auto. & Semi Auto. Lytic Ag.	Abbott Diagnostics	GGK	Class I	1987-09-09
K873347	Cell-Dyn Diff. Screen Isotonic Diluent	Abbott Diagnostics	GIF	Class I	1987-09-09
K873191	Acromed Interbody Depth Gauges	Buckman Co., Inc.	HTJ	Class I	1987-09-09
K873175	Central Supply Room Wrap	Ulti-Med Intl., Inc.	FRG	Class II	1987-09-09
K873136	Mmg Cath-N-Place	Medical Technologies of Georgia	KNX	Class II	1987-09-09
K873088	Virgo(tm) Rubella Igg Elisa	Electro-Nucleonics Laboratories, Inc.	LFX	Class II	1987-09-09
K871830	Napsac(tm)	Beecher Medical Diagnostic Instrumentation	GKL	Class II	1987-09-09
K864999	Kennedy Stem	Allo Pro Corp.	JDI	Class II	1987-09-09
K873470	Template	Cox-Uphuff Intl.	FTY	Class I	1987-09-08
K873408	Model 690 Spectrophotometer	Abbott Diagnostics	JJQ	Class I	1987-09-08
K873378	Gamma Glutamyltransferase	Catachem, Inc.	JQB	Class I	1987-09-08
K873352	Rapid Electrophoresis System (Rep)	Helena Laboratories, Corp.	JJN	Class I	1987-09-08
K873332	Maxivac(tm) Closed Wound Suction Drainage System	American V. Mueller	GCY	Class I	1987-09-08
K873272	Endoscopy Table 1532 Endostar	Stierlen-Maquet AG	BWN	Class I	1987-09-08
K873160	Biotrol Triglycerides Enzymatique Color	Biotrol, USA, Inc.	CDT	Class I	1987-09-08
K873124	Anchor Biopsy Needle	Anchor Products Co.	GAA	Class I	1987-09-08
K872307	Volumetric Package Stepper H4222aa/calcu. H4222ab	General Electric Co.	IYO	Class II	1987-09-08
K872302	Model 550 Express Clinical Chemistry Analyzer	Ciba Corning Diagnostics Corp.	JJE	Class I	1987-09-08
K871865	Series 2900 Synthetic Contact Tips, Gu Use	Sharplan Lasers, Inc.	LNK	Class II	1987-09-08
K870850	Mod 482	Hoffrel Instruments, Inc.	JOP	Class II	1987-09-08
K873338	Horn Custom Aid	Hearing Aids by Guy Horn	ESD	Class I	1987-09-04
K873313	Surgical Drape	American Medical Technology, Inc.	KKX	Class II	1987-09-04
K873164	Van Dellen Healon Cannula	Van Dellen, Ltd.	HMX	Class I	1987-09-04
K873163	Van Dellen Irrigating Cystotome	Van Dellen, Ltd.	HNY	Class I	1987-09-04
K873162	Van Dellen Retrobulbar Needle	Van Dellen, Ltd.	HMX	Class I	1987-09-04
K873154	Treace Magnum Oto-Tool System	Treace Medical, Inc.	ERL	Class II	1987-09-04