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 2827 of 3529

510(k) clearances, page 2827 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K870525	Philips Model Sl75-10 Linear Accelerator	Industrial Accelerator Co.	IYE	Class II	1987-04-01
K870504	Norta (Tm) Urobag	Beiersdorf, Inc.	KNX	Class II	1987-04-01
K870390	Phenobarbital (Fpia) Calibrator Kit	Windsor Laboratories, Inc.	DLJ	Class II	1987-04-01
K870389	Digoxin (Fpia) Calibrator Kit	Windsor Laboratories, Inc.	DLJ	Class II	1987-04-01
K870355	(Ureteroscopic) Stricture Scapel or Knife	Cook Incorporated	OCZ	Class II	1987-04-01
K870332	Prefilled Respiratory Therapy Vials	Automatic Liquid Packaging, Inc.	CCQ	Class I	1987-04-01
K870261	Viggo Exacta Pressure Monitoring System	GE Healthcare	FMG	Class II	1987-04-01
K870245	Autopak Tsh Monoclonal Irma Kit	Micromedic Systems	JLW	Class II	1987-04-01
K870244	Iq Tsh Immunoassay	BD Becton Dickinson Vacutainer Systems Preanalytic	JLW	Class II	1987-04-01
K870168	Empi Logix Model 712 Nms, TENS	Empi	GZJ	Class II	1987-04-01
K870160	Dynex Disposable Self-Adhering Electrode W/tens	La Jolla Technology, Inc.	GXY	Class II	1987-04-01
K870136	Personal Punch	Arnold Technologies	EXB	Class I	1987-04-01
K870019	The Lahr Balloon	Plasco, Inc.	FCE	Class I	1987-04-01
K864900	Viggo Exacta Pressure Monitoring Kit	GE Healthcare	FMG	Class II	1987-04-01
K864114	TENS Device for Relief of Chronic Pain	Futuremed Div. of Future Impex Corp.	GZJ	Class II	1987-04-01
K862921	Model 10200 Premature Infant Incubator	Rotem Industries C/O Medsys, Inc.	FMT	Class II	1987-04-01
K871175	Jumbo Digital Gammacamera, Gca-901A	Toshiba Medical Systems	IYX	Class I	1987-03-31
K871145	Edec 50C Constant Potential X-Ray Generator	Electromed Intl., Ltd.	IZO	Class I	1987-03-31
K871119	Canon X-Ray Image Distributor Cxi-3-3D	Canon Medical Components U.S.A., Inc.	JAA	Class II	1987-03-31
K871056	Medicam S-4 Surgical Camera	M.P. Video, Inc.	FWF	Class I	1987-03-31
K871041	RF Microassay	Diamedix Corp.	DHR	Class II	1987-03-31
K871033	Rabbit Kidney Culture Cells (First Pass)	Microscan Div. Baxter Healthcare Corp.	KIR	Class I	1987-03-31
K871005	18X36,36x36,18x72,24x72 Gauze Compress	Advantage Credit Services, Inc.	EFQ	Unclassified	1987-03-31
K871002	1X5yd,2x6yd,3x5yd,4x6yd,1/2/3x10yd Gauze	Advantage Credit Services, Inc.	EFQ	Unclassified	1987-03-31
K870993	2, 3 and 4 Bandage Compress	Advantage Credit Services, Inc.	EFQ	Unclassified	1987-03-31
K870953	Phenytoin Fpia Reagent Set	Sigma Diagnostics, Inc.	DIP	Class II	1987-03-31
K870952	Theophylline Fpia Reagent Set	Sigma Diagnostics, Inc.	KLS	Class II	1987-03-31
K870938	Fetal Bovine Serum	Hyclone Laboratories, Inc.	KIS	Class I	1987-03-31
K870932	Surgifresh Surgical Smoke Removal	Texas Medical Products, Inc.			1987-03-31
K870900	The Gripper Seal(tm)	Pharmacia Deltec, Inc.	KGX	Class I	1987-03-31
K870887	Ward's Breast Measuring Device	Downs Surgical, Ltd.			1987-03-31
K870876	Hl-1 Supplement	Ventrex Laboratories, Inc.	KIT	Class I	1987-03-31
K870852	Nbf 10% Neutral Buffered Formalin	Anatech, Ltd.	IFP	Class I	1987-03-31
K870800	T2570 Thio W/o Ind W/o Dextrose	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-03-31
K870799	T2500 Fluid Thio	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-03-31
K870798	T7202 Thio W/o Ind W/dextrose	Lakewood Biochemical Co., Inc.	JSG	Class I	1987-03-31
K870787	Abbott Spectrum Ammonia Reagent	Abbott Medical	JIF	Class I	1987-03-31
K870754	Mcghan Tissue Expander Fill System	Mcghan Medical Corp.	LCJ	Unclassified	1987-03-31
K870688	O.o2 M Calcium Chloride Solution	U. S. Diagnostics, Inc.	JPA	Class II	1987-03-31
K870603	System 9000 Automated Cell Counter	Baker Instructions Corp.	GKL	Class II	1987-03-31
K870514	Threshold(tm) Inspiratory Muscle Trainer	Health Products, Inc.	BWF	Class II	1987-03-31
K870115	Berthold Lb 2103,2104-Xt/pc/at,951g Gamma Counters	Berthold Analytical Instruments, Inc.	JJJ	Class I	1987-03-31
K864993	Quali. Enzyme Immuno. of Barbiturates in Urine	General Diagnostics	DIS	Class II	1987-03-31
K864928	Bio-Log 8+1 Ambulatory Physiologic Recorder	Bio-Scan, Inc.	GWQ	Class II	1987-03-31
K864552	Port-a-Cath Implantable Catheter System	Pharmacia, Inc.	LLD	Class II	1987-03-31
K864446	Port-a-Cath Vascular Access Systems	Pharmacia, Inc.	LJT	Class II	1987-03-31
K864256	Tryptone Water (1%)	Mds Laboratories, Inc.	JSF	Class I	1987-03-31
K864255	Trypticase Soy Broth	Mds Laboratories, Inc.	JSG	Class I	1987-03-31
K864254	Thioglycollate Broth	Mds Laboratories, Inc.	JSG	Class I	1987-03-31
K864253	Thayer Martin Agar	Mds Laboratories, Inc.	JTY	Class II	1987-03-31