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 2863 of 3529

510(k) clearances, page 2863 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K863648	Seracon CT Reference	Bhp Diagnostix, Inc.	JJY	Class I	1986-10-29
K863478	Cerebrospinal Fluid Protein Testpack, #67668/95	Em Diagnostic Systems, Inc.	JGQ	Class II	1986-10-29
K863437	Bard Balloon Dilatation System	C.R. Bard Inc	FGE	Class II	1986-10-29
K863434	The Fiax 5000 Fluorometer	Whittaker Bioproducts, Inc.	JZT	Class I	1986-10-29
K863323	Sengewald Catalog Number 55 66 01	Sengewald/USA, Inc.	KKX	Class II	1986-10-29
K863224	Hematall-C Plus Hematology Controls	Fisher Scientific Company L.L.C.	JPK	Class II	1986-10-29
K862991	Ligament Washer	Mizuho Orthopedic Systems Inc	HRX	Class II	1986-10-29
K862990	Cancellous Screw	Mizuho Orthopedic Systems Inc	HRX	Class II	1986-10-29
K862757	Starchild Sleepdry	Starchild, Inc.	KPN	Class II	1986-10-29
K862339	Mevatron Kd-2	Siemens Medical Laboratories, Inc.	IYE	Class II	1986-10-29
K861883	Immunochemical Assay of Apolipoprotein A1	Orion Corp.	MSJ	Class I	1986-10-29
K861882	Immunochemical Assay Apolipoprotein B	Orion Corp.	MSJ	Class I	1986-10-29
K861634	The Wellcome Rotavirus Latex Test Zl40	Wellcome Diagnostics	LIQ	Class I	1986-10-29
K863165	Model 4-Sc Four Way Stopcock	Life-Tech Intl., Inc.	FAP	Class II	1986-10-28
K861044	Model 2100 Nd:yag Surgical Laser Neurosurgical Ind	Sharplan Industries, Inc.	GEX	Class II	1986-10-28
K864042	Mammographic Model Cxr 51 Mo-6'/0.6 Sh	Absolute X-Ray Corp.	ITY	Class I	1986-10-27
K863912	The Mmg 5 in 1 Connector	Medical Marketing Group	BYX	Class I	1986-10-27
K863883	Models 4002/4102/4202 Oxy. Delivery/co2 Cannula	Salter Labs	CCK	Class II	1986-10-27
K863816	Ivory Premium Rubber Dam	Columbus Dental Mfg. Co.	EIE	Class I	1986-10-27
K863778	Venticis II	Cis-Us, Inc.	IYT	Class II	1986-10-27
K863768	Saliva Ejectors	Medical Group	DYN	Class I	1986-10-27
K863764	Cotton Rolls, Non-Sterile	Medical Group	EFN	Class I	1986-10-27
K863629	Kodak Ektascan Laser Printer, Model 100	Eastman Kodak Company	LMC	Class II	1986-10-27
K863286	Ers System	General Electric Co.	LMB	Class I	1986-10-27
K863180	Theratron-Phoenix	Aecl Medical	IWB	Class II	1986-10-27
K863087	Spiroloop-Pulmonary Exercise System	Pneumedics, Inc.	BTY	Class II	1986-10-27
K862861	Surgical Carbon Dioxide Sys. Model 10-C Ob-Gyn Use	Directed Energy, Inc.	HHR	Class II	1986-10-27
K862842	Advanced Nuclear Computer	Advanced Nuclear Imaging Corp.	LMB	Class I	1986-10-27
K862672	Esophageal Stethoscope with Thermistor	Inmed Corp.	BZT	Class II	1986-10-27
K861433	Universal Acetabular Component	Zimmer GmbH	JDI	Class II	1986-10-27
K864040	Bard Eska Jonas Silicone-Silver Penile Prosthesis	C.R. Bard Inc	FAE	Class II	1986-10-24
K864008	Acclaim* Bracket Adhesive	Johnson & Johnson Professionals, Inc.	DYH	Class II	1986-10-24
K863982	Vas-Cath Pericardiocentesis Catheter, Set & Tray	Vas-Cath of Canada, Ltd.	JCY	Class I	1986-10-24
K863976	Ocean Scientific Vacutest	Ocean Scientific, Inc.	JKA	Class II	1986-10-24
K863964	Limb-Guard	Sparco, Inc.			1986-10-24
K863957	Tubegripper, Drainage Catheter & Accessory for Gu	Cathaid, Inc.	FGE	Class II	1986-10-24
K863951	P.s.i.-Disposable Scalpel Surgeons Handle	Precision Surgical Industries, Inc.	GDZ	Class I	1986-10-24
K863950	P.s.i.-Disposable Metal Handle Surgeons Scalpel	Precision Surgical Industries, Inc.	GDX	Class I	1986-10-24
K863942	Porex(tm) Nose Prosthesis	Porex Medical	FZE	Class II	1986-10-24
K863941	Porex(tm) Prosthesis, Chin, Internal	Porex Medical	FWP	Class II	1986-10-24
K863939	Porex(tm) Ear Prosthesis	Porex Medical	FZD	Class II	1986-10-24
K863932	Gauze, Absorbent, Sterile, Compressed	Fraass Survival Systems, Inc.	EFQ	Unclassified	1986-10-24
K863885	Sable Blades	Sable Industries, Inc.	GES	Class I	1986-10-24
K863871	Operating Room Towels - Sterile/non Sterile	Med-Tex, Inc.	KKX	Class II	1986-10-24
K863870	Gauze, Nonabsorbable, Non-Medicated (Internal)	Med-Tex, Inc.	EFQ	Unclassified	1986-10-24
K863867	Dextra Disposable Blades	Storz Instrument Co.	GES	Class I	1986-10-24
K863824	Solution/test Standard/conduct. Dialy.&mult.solut.	D.R.G. Scientific Industries	FKH	Class II	1986-10-24
K863777	B-Wrap	Bdf Plaza			1986-10-24
K863774	Contour Cup Masks	Medical Group			1986-10-24
K863761	2X2 Sponges, Non-Sterile, Cotton Filled	Medical Group	EFQ	Unclassified	1986-10-24