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 2768 of 3530

510(k) clearances, page 2768 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K874215	Endoscopes for Sinus Surgery	Richards Medical Co., Inc.	EOB	Class II	1988-01-04
K874076	Modified Omnistim(tm) Electrical Muscle Stimulator	Physio Technology, Inc.	IPF	Class II	1988-01-04
K872265	Ultrasound Breast Scanner W/changes in Trans/rece.	Labsonics, Inc.	HGL	Class II	1988-01-04
K874742	Quicktrach	Posey Co.	BTO	Class II	1987-12-31
K874100	Aml Calcar Femoral Prosthesis	Depuy, Inc.	JDG	Class II	1987-12-31
K874081	Enterscan	Pie Data Medical BV	LWI	Class II	1987-12-31
K874062	Enteron Liver Biopsy Tray	Endovations	KNW	Class II	1987-12-31
K873970	Kirschner Unicondylar Knee System	Kirschner Medical Corp.	HSX	Class II	1987-12-31
K873626	Freeman Total Hip System Titanium Modular System	Mizuho Orthopedic Systems Inc	JDI	Class II	1987-12-31
K873125	Soken(tm) Electronic Muscle Stimulator	Rehab Medical Specialties, Inc.	IPF	Class II	1987-12-31
K875021	Ace and Ace/fischer Pre-Drill Pin System	Buckman Co., Inc.	JDW	Class II	1987-12-30
K874965	Manual Surgical Instruments for General Use	Solway, Inc.	HTD	Class I	1987-12-30
K874961	Bone Cutting Instruments & Accessories	Solway, Inc.	GDR	Class I	1987-12-30
K874959	Vascular Clamp	Solway, Inc.	HXD	Class I	1987-12-30
K874954	Manual Rongeur	Solway, Inc.	HTX	Class I	1987-12-30
K874952	Manual Cranial Drill, Burr, Trephine & Accessories	Solway, Inc.	HBG	Class II	1987-12-30
K874950	Microsurgical Instruments	Solway, Inc.	HTD	Class I	1987-12-30
K874928	Wholey (Tm) Biopsy Device	Medrad, Inc.	GDM	Class I	1987-12-30
K874889	u.v. Sunlamp 95 Uf-11	Light Sources, Inc.	FTC	Class II	1987-12-30
K874888	Isolation Gown	Sage Products LLC	FYC	Class II	1987-12-30
K874880	Colored Casting Tape Caraglas(tm Green	Synthetic Mfg., Inc.	LGF	Class I	1987-12-30
K874687	Colli-Matetm Model No. B800	Summit Industries, LLC	IZX	Class II	1987-12-30
K874653	Sterile Surgical Scrub Brush	Surgikos, Inc.	GEC	Class I	1987-12-30
K874513	Monaghan Aerochamber with Mask	Monaghan Medical Corp.	CCQ	Class I	1987-12-30
K874479	Mc/cpap Manifold	Minneapolis Children'S Services Corp.	BYE	Class II	1987-12-30
K874446	Multi-Allergen Ige Fast Screen (Environmental)	3M Company	DHB	Class II	1987-12-30
K874437	Trauma-Trode, ECG Electrode (597 Adhesive)	Labeltape Meditect, Inc.	DRX	Class II	1987-12-30
K874405	Pall Stat Prime(tm) Blood Filter for Extra. Use	Pall Biomedical Products Co.	JOD	Class II	1987-12-30
K874386	Cbc-Tech(tm) Hematology Control/multiple	R & D Systems, Inc.	JCN	Class II	1987-12-30
K874378	Dinamap Vital Signs Monitor, Model 8100T	Critikon Company, LLC	DXN	Class II	1987-12-30
K874184	Chemo-Port	Hdc Corp.	LJT	Class II	1987-12-30
K874032	Irma-Count Lh W/mono. Antibodies Rklh1,2,5	Siemens Healthcare Diagnostics Inc.	CEP	Class I	1987-12-30
K874022	Pharmaseal Wound Irrigation Device	American Pharmaseal Div. Ahsc	FQH	Class II	1987-12-30
K874000	Pria-Kit (Tm) Priapism Kit S.s.	Canton Medical, Inc.	GAA	Class I	1987-12-30
K873991	Lake Irrigation Tray	Lake Medical Products, Inc.	FMI	Class II	1987-12-30
K873627	Cti Straight Stem	Mizuho Orthopedic Systems Inc	JDG	Class II	1987-12-30
K873605	Comfort Machine for Desensitization/anesthesia Use	Pain Prevention Laboratory, Inc.	LWM	Unclassified	1987-12-30
K873579	Ambu Rmt Valve	Ambu, Inc.	BWF	Class II	1987-12-30
K873495	Pump Tubing Set	Marquette Medical, Inc.	FRN	Class II	1987-12-30
K873494	Reservoir Bag	Marquette Medical, Inc.	FRN	Class II	1987-12-30
K873291	Msi 9000 Series Bed	Med Service, Inc.	FNL	Class II	1987-12-30
K873248	Gastrointestinal Flexible Biospy Forceps	Medical Engineering Laboratory, Inc.	OCZ	Class II	1987-12-30
K873166	Bcm Dry Pack Bicarbonate Mixer	Specialty Dialysis Services	FIN	Class II	1987-12-30
K872352	Fiberlase II Nd:yag Laser for Treat of Menorrhagia	Laser Media	HHR	Class II	1987-12-30
K870899	Ezu-Pc 2A/5.0 & 3A/3.5mhz, Eup-Cd 121/5.0 Convex	Biosound, Inc.	ITX	Class II	1987-12-30
K874878	Gen-Probe(r) Pace(tm) System Chlamydia Trachomatis	Hologic, Inc.	LSK	Class I	1987-12-29
K874632	Bent Neck Curlcath Peritoneal Dialysis Kit	Quinton, Inc.	FKX	Class II	1987-12-29
K874582	Deseret Splittable Catheter	Deseret Medical, Inc.	FOZ	Class II	1987-12-29
K874504	Micro-Aire Pulse Lavage	Micro-Aire Surgical Instruments, Inc.	FQH	Class II	1987-12-29
K874459	Liqui-Sera Spinal Fluid Control	Biodiagnostic Intl	JJY	Class I	1987-12-29