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 2772 of 3530

510(k) clearances, page 2772 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K873254	Thermowrap, A/k/a/, Thermal Wrap	Family Sun Tanning	IRT	Class II	1987-12-11
K872861	Loviel Condom	Lloviel Marketing Corp.	HIS	Class II	1987-12-11
K872351	Fiberlase II Nd:yag Laser for Pulmonary Use	Laser Media	LLO	Class II	1987-12-11
K872125	Bard Abg 100 Intravascular Oxygen Monitor. System	C.R. Bard Inc	CCE	Class II	1987-12-11
K871616	Custom Procedure Trays	Medical Custom Products, Inc.	FMF	Class II	1987-12-11
K871420	Herpes 1 and 2 Microassays	Diamedix Corp.	GGC	Class II	1987-12-11
K871004	Eub-410 Diagnostic Ultrasound Device	Hitachi Medical Corp. of America	IYO	Class II	1987-12-11
K874766	Interpro Int'l, Inc. Isolation Gown	Interpro Intl., Inc.	FYC	Class II	1987-12-10
K874764	Hearing Aid (All-in-the-Ear) Model Word Sorter	Clear Corp.	ESD	Class I	1987-12-10
K874762	Arthrotract Upper Limb Traction Accessory	Andronic Devices, Ltd.	JEA	Class I	1987-12-10
K874760	Ck 4900 Series, Gown and Towel Pak	Currie Medical Specialties, Inc.	LRO	Class II	1987-12-10
K874744	Oticon Model I50 in-the-Ear Hearing Aid	Oticon, Inc.	ESD	Class I	1987-12-10
K874741	Steri-Clens(tm) Surgical Scrub Sponge	Absorbent Cotton Co., Inc.	GEC	Class I	1987-12-10
K874617	Thompson Hip Prosthesis	Mizuho Orthopedic Systems Inc	JDG	Class II	1987-12-10
K874375	Abbott Testpack Rotavirus Positive Control	Abbott Medical	LIQ	Class I	1987-12-10
K874196	Power Exercise Equipment	Arc Motion, Ltd.	BXB	Class I	1987-12-10
K874060	Converta-Litter	Camtec	INN	Class I	1987-12-10
K873812	Sonicator 720 (Model Me720)	Mettler Electronics Corp	IMI	Class II	1987-12-10
K873794	Hot Rod Thermal Massage Roller	American Progressive Products Corp.	ISA	Class I	1987-12-10
K873723	Plaster Vacuum, 230V Model No. 4183-161	Martin Medical	LGH	Class I	1987-12-10
K874650	Peritoneal Dialysis Kit (Acute and Chronic Form)	Quinton, Inc.	FKO	Class II	1987-12-09
K874466	Api Uniscept(r) Micro-Mic(r) System/uniscept Mic	Analytical Products, Inc.	JWY	Class II	1987-12-09
K874078	Meritec(tm)-Gc	Meridian Diagnostics, Inc.	LIC	Class II	1987-12-09
K873887	Modified Hollow Fibers Used in Diafilter Hemofil.	W.R. Grace & Co.-Conn.	KDI	Class II	1987-12-09
K874718	Standard Latex Condoms (Ramses, Sheik and Koromex)	Schmid Laboratories, Inc.	HIS	Class II	1987-12-08
K874657	Rigid-Lens Case	Sola Ophthalmics	LRX	Class II	1987-12-08
K874071	Mother's Milk Bag	Yanase Waitch K.K.	HGX	Class II	1987-12-08
K873806	Jdm Sp2 Sensor	Jd Monitoring C/O Mackler, Cooper and Gibbs	KMI	Class I	1987-12-08
K873763	Bio-Oss - Ceramic Pure Natural Hydroxyapatite	Geistlich Pharma AG	LYC	Class II	1987-12-08
K873736	Nicolet Digital Two Piece Hearing Aid	Nicolet Biomedical Instruments	ESD	Class I	1987-12-08
K873300	Service Master (Impulse)	Richards Medical Co., Inc.	LRB	Class I	1987-12-08
K873003	Hearing Aid (All-in-the-Ear)	Acoustical Hearing Services, Inc.	ESD	Class I	1987-12-08
K872799	Kimono (Condoms)	Mayer Laboratories	HIS	Class II	1987-12-08
K872645	Air Conduction in-the-Ear Hearing Aid Ua/115/scr	Richards Medical Co., Inc.	LRB	Class I	1987-12-08
K871451	Bestcon/spermicide	Europharmaceutical Corp.	HIS	Class II	1987-12-08
K874628	Resubmitted Standard Micropore ECG Electrode	Labeltape Meditect, Inc.	DRX	Class II	1987-12-07
K874393	Enteral Feeding Tube	Wilson-Cook Medical Inc.	KNT	Class II	1987-12-07
K874314	Wilson-Cook Biopsy Forceps	Wilson-Cook Medical Inc.	KNW	Class II	1987-12-07
K874309	Urethal Catheter	Medovations, Inc.	KNX	Class II	1987-12-07
K874259	Trichomonas Direct Enzyme Immunoassay	California Integrated Diagnostics, Inc.	JWZ	Class I	1987-12-07
K874242	Jehle Coronary Perfusion Catheters	Pilling Co.	KRA	Class II	1987-12-07
K874238	Model 2001 Cp, Photon I, Dental, Intraoral X-Ray	Belmont Equipment Corp.	EHD	Class II	1987-12-07
K874167	Medtronic Permanent Lead Introducer	Medtronic, Inc.	DTB	Class III	1987-12-07
K874164	Guide Wire	Endovations	EZB	Class I	1987-12-07
K874130	Titanium Bone Screws	Mizuho Orthopedic Systems Inc	HWC	Class II	1987-12-07
K874107	H.t.u. (Hyperbaric Therapy Unit)	Hyox Systems C/O Mechidyne Systems, Inc.	CBF	Class II	1987-12-07
K873977	New C-D System for Spinal Surgery	Sofamor Co.	JDN	Class II	1987-12-07
K873930	Aerosol Delivery System (Aero-Tech II)	Cadema Medical Products, Inc.	CAF	Class II	1987-12-07
K873847	Cormed III Ambulatory Infusion Pump	C.R. Bard Inc	FRN	Class II	1987-12-07
K873721	Plaster Vacuum, 115V Model No. 4183-160	Martin Medical	LGH	Class I	1987-12-07