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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 1918 of 3531

510(k) clearances, page 1918 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K964924	Omega Total Hip System for Use without Bone Cement (Line Extension)	Osteoimplant Technology, Inc.	LPH	Class II	1997-03-07
K964528	(Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue Tint	Benz Research and Development LLC	LPL	Class II	1997-03-07
K962731	Hycor Hy.tec/manual Jo-1 Auto-Antibody	Hycor Biomedical	LLL	Class II	1997-03-07
K962730	Hycor Hy.tec/manual Ds-DNA Auto-Antibody	Hycor Biomedical	LRM	Class II	1997-03-07
K962729	Hycor Hy.tec/manual RF Auto-Antibody	Hycor Biomedical	DHR	Class II	1997-03-07
K962728	Hycor Hy.tec/manual Ena Auto-Antibody	Hycor Biomedical	LLL	Class II	1997-03-07
K962727	Hycor Hy.tec/manual Rnp Auto-Antibody	Hycor Biomedical	LLL	Class II	1997-03-07
K962722	Hycor Hy.tec/manual Sm Auto-Antibody	Hycor Biomedical	LLL	Class II	1997-03-07
K962720	Hycor Hy.tec/manual Scl-70 Auto-Antibody	Hycor Biomedical	LLL	Class II	1997-03-07
K962719	Hycor Hy.tec/manual Ss-a Auto-Antibody	Hycor Biomedical	LLL	Class II	1997-03-07
K962578	Hycor Hy.tec/manual Ss-B Auto-Antibody	Hycor Biomedical	LLL	Class II	1997-03-07
K962545	Dental, Medical Instrument Cases & Cassette	Sterilization Cassette Systems, Inc.	KCT	Class II	1997-03-07
K962446	Sharplan Ruby Laser System	Sharplan Lasers, Inc.	GEX	Class II	1997-03-07
K961892	Specktin-La Test Set	Analytical Control Systems	GFO	Class II	1997-03-07
K944180	Model 700	Memtec Corp.	DSH	Class II	1997-03-07
K970459	Elecsys Calcheck Cea	Boehringer Mannheim Corp.	JJX	Class I	1997-03-06
K970458	Elecsys Calcheck Psa	Boehringer Mannheim Corp.	JJX	Class I	1997-03-06
K970452	Elecsys Calcheck Cea	Boehringer Mannheim Corp.	JJX	Class I	1997-03-06
K970425	Ez Sure Urine Dipstick Pregnancy Home Test	Excel Scientific, Inc.	LCX	Class II	1997-03-06
K970424	Excel One Step Urine Hcg Pregnancy Dipstick Test	Excel Scientific, Inc.	JHI	Class II	1997-03-06
K970391	Quantum Edge Pediatric Defirbrillation Electrodes	Contour Medical Technology, Inc.	MKJ	Class III	1997-03-06
K970282	Medline Circumcision Tray	Medline	HFX	Class II	1997-03-06
K970212	Levofloxacin, 5Mcg, Sensi-Disc	Becton Dickinson Microbiology Systems	JTN	Class II	1997-03-06
K970124	Lipase Reagent Set (Colipase Method)	Teco Diagnostics	CET	Class I	1997-03-06
K970087	Cr Perfect	Chimera Research & Chemical, Inc.	CGX	Class II	1997-03-06
K965194	Medicom, TENS Electrodes	Medicotest, Inc.	GXY	Class II	1997-03-06
K965108	Synchron Lx Systems Immunoglobulin G/a/m Reagent	Beckman Instruments, Inc.	DEW	Class II	1997-03-06
K965078	2.1Mm Semi-Rigid Neuroview Scissors/2.0omm Semi-Rigid Neuroview Grasping Forceps	Neuro Navigational Corp.	GWG	Class II	1997-03-06
K965070	Spectrum 5000 Q, 5000Q,m,4000 Q, 4000 M.	Mecta Corp.	QGH	Class II	1997-03-06
K965055	Imagyn Microlap and Micro Lap-Gold Laparoscopes	Imagyn Medical, Inc.	HET	Class II	1997-03-06
K964988	Coulter Ac.t Series Analyzer	Coulter Corp.	GKZ	Class II	1997-03-06
K964980	Ultrex Powder-Free Surgical Gloves/ultrex Powder-Free Surgical Gloves with Low Protein Claim	Maxxim Medical	KGO	Class I	1997-03-06
K964967	Biocor 200 High Performanceoxygenator	Medivators Inc	DTZ	Class II	1997-03-06
K964962	Sentura Surgical Gloves	Maxxim Medical	KGO	Class I	1997-03-06
K964939	The Portable Family - Medi-Facts Dx1 Portable Lite and Dx1 Portable Plus	Creative Biomedics, Inc.	BZC	Class II	1997-03-06
K964890	Anatom 2000	Analogic Corp.	JAK	Class II	1997-03-06
K964843	Immage Immunochemistry System Properdin Factor B (Pfb) Reagent	Beckman Instruments, Inc.	JZH	Class II	1997-03-06
K964609	Actalyke Activated Clotting Time Test System/clotting Time Tubes/whole Blood Qc Kit/actalyke Electronic Clotting Tube	Array Medical, Inc.	JBP	Class II	1997-03-06
K964385	Elias Ana-Hep-2	Elias U.S.A., Inc.	LJM	Class II	1997-03-06
K964066	Dual Slim Port Implanted Port (0654970/0654940)	C.R. Bard Inc	LJT	Class II	1997-03-06
K963974	Image-Immunochemistry System Urine Immunoglobulin	Beckman Instruments, Inc.	DEW	Class II	1997-03-06
K962781	Corometrics Model 510 and 511 Monitor	GE Medical Systems Information Technologies, Inc.	BZQ	Class II	1997-03-06
K962547	Cardioserv P	Marquette Electronics, Inc.	DRO	Class II	1997-03-06
K962327	Sekure Seat Adult Passive Restraining Device	Sekure Seat Corp.	FMQ	Class I	1997-03-06
K960072	Spirit Hematology System Model Le, Cp, & Ax	Biochem Immunosystems (U.S.), Inc.	GKZ	Class II	1997-03-06
K954488	Roller Electrode	OLYMPUS Corporation of the Americas	HIH	Class II	1997-03-06
K951632	Ortho-Mune Ok-Combo Control Igg2a-Fitc/igg2a-Pe Monoclonal Antibody (Murine)	Ortho Diagnostic Systems, Inc.	GKZ	Class II	1997-03-06
K970152	Biopsy Tray	Medcare Medical Group, Inc.	FRG	Class II	1997-03-05
K970055	Karl Storz Multidrive II Mini Shaver for Arthroscopy	Karl Storz Endoscopy-America, Inc.	HRX	Class II	1997-03-05
K970045	Solaro 33	Metalor Dental USA Corp.	EJS	Class II	1997-03-05