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 2026-10-29, 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 2612 of 3530

510(k) clearances, page 2612 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K894718	Adaptaid(tm) Adapter Sleeve Model 366-33	Intermedics, Inc.	DTD	Class II	1989-09-05
K894648	Arbo Tab Disposable Diagnostic Resting EKG Electro	Arbo Medical, Inc.	DRX	Class II	1989-09-05
K894646	#556 Disposable Umbilical Cord Clamp (2)	Alpha Unlimited, Inc.	HFW	Class II	1989-09-05
K894562	Arbo H79p Disposable Monitoring Electrodes	Arbo Medical, Inc.	DRX	Class II	1989-09-05
K894503	Gemtab System	Pharmacia Eni Diagnostics, Inc.	JJQ	Class I	1989-09-05
K894467	Thrombin Time Reagent	Sigma Chemical Co.	GJA	Class II	1989-09-05
K894466	Hepcon(r) Cv Whole Blood Coagulation Controls	Hemotec, Inc.	JPA	Class II	1989-09-05
K894408	Abbott Testpack Plus Hcg Urine	Abbott Medical	JHI	Class II	1989-09-05
K894359	Clotrac Citrated Whole Blood Coagulation Controls	Hemotec, Inc.	JPA	Class II	1989-09-05
K894329	Radioassay Controls 31 & 32, Anti-Dsdna Control	Amersham Corp.	JJX	Class I	1989-09-05
K894317	Hemotec Hepcon Hms Coagulation System & Access.	Hemotec, Inc.	JOX	Class II	1989-09-05
K894173	Bun-Blood Urea Nitrogen for Manual/auto Applicat	Catachem, Inc.	CDQ	Class II	1989-09-05
K894148	Mod. Femoral Comp. Non-Beaded & Basic Ace. Shell	Howmedica Corp.	JDI	Class II	1989-09-05
K894146	Gram Negative and Positive Mic/combo Panels	Baxter Healthcare Corporation	JWY	Class II	1989-09-05
K894145	Emit T-Uptake Assay	Syva Co.	KHQ	Class II	1989-09-05
K894101	Roche Reagent for Uric Acid	Roche Diagnostic Systems, Inc.	KNK	Class I	1989-09-05
K894003	Patient Examination Gloves	Beekay Hygiene Products	LYY	Class I	1989-09-05
K893963	Veripoid 50 Bio-Electrical Impedance Meter	V.S.B.B. Technologies, Inc.	DSB	Class II	1989-09-05
K893778	Calcium Test Item Number: 65409	Em Diagnostic Systems, Inc.	CIC	Class II	1989-09-05
K893587	Oximeter	Radiometer America, Inc	DQA	Class II	1989-09-05
K893474	Bard Cath Lab Thermodilution Catheter	C.R. Bard Inc	DYG	Class II	1989-09-05
K893418	Myocardial Probe Thermometer Code 64000	Dlp, Inc.	FLL	Class II	1989-09-05
K893411	Stealth Dilation Catheter System	Target Therapeutics	LIT	Class II	1989-09-05
K893216	Rmi Ultrasound Doppler Phantom System	Radiation Measurements, Inc.	GXX	Class I	1989-09-05
K893049	Landscape Patient Examination Gloves	Pacific Intl. Economic & Technical, Inc. U.S.A.	LYY	Class I	1989-09-05
K892994	Non-Sterile Vinyl Examination Gloves	Sian-Yu Industrial Co., Ltd.	LYZ	Class I	1989-09-05
K892081	Patient Examination Gloves (Latex)	Tacare Products, Ltd.	LYY	Class I	1989-09-05
K892080	Patient Examination Gloves (Latex)	The Orient Connection	LYY	Class I	1989-09-05
K892070	General Ivt Needle Guide Kit, Sterile	Amedic USA	HGL	Class II	1989-09-05
K891265	Latexco Latex Examination Gloves	Latex Products Co., Inc.	LYY	Class I	1989-09-05
K890687	Ect-100 Electronic Corneal Topographer	Optimed, Inc.	HLQ	Class I	1989-09-05
K885133	Apaceram Artificial Dental Implant	Asahi Optical Co. C/O Rosati Associates, P.C.	DZE	Class II	1989-09-05
K894532	Fpr Tobramycin Calibrator Kit	Colony Laboratories, Inc.	DLJ	Class II	1989-09-01
K894531	Fpr Tobramycin Kit	Colony Laboratories, Inc.	LFW	Class II	1989-09-01
K894269	CT Hilight Advantage	GE Healthcare	JAK	Class II	1989-09-01
K894263	Cass System	Medical Instrumentation & Diagnostics Corp.(Midco)	HAW	Class II	1989-09-01
K894021	Mobile X-Ray Unit	Ziehm International, Inc.	IZL	Class II	1989-09-01
K893978	Medisys Record and Verify System	Medisys, Inc.	IYE	Class II	1989-09-01
K893595	Patient Examination Gloves	Arcofield, Ltd.	LYY	Class I	1989-09-01
K893591	Latex Examination Gloves	Shanghai Medicines & Health Products Import & Expo	LYY	Class I	1989-09-01
K892485	Patient Examination Gloves (Latex)	Intl. Pacific Industrial Corp. (USA), Inc.	LYY	Class I	1989-09-01
K892181	Patient Exam Gloves (Mfg. Shanghai Latex Factory)	Grand Monde Trading Co., Inc.	LYY	Class I	1989-09-01
K892084	Patient Examination Gloves (Latex)	Mirano Sdn. Bhd.	LYY	Class I	1989-09-01
K892083	Shih Kuo Latex Exam Glove	Beverly Ent., Inc.	LYY	Class I	1989-09-01
K892079	Champ-Paq Vinyl Patient Exam Gloves	Winmed Instruments Mfg. Corp.	LYZ	Class I	1989-09-01
K892072	Patient Examination Gloves (Latex)	Gaw Rubber Products Sdn. Bhd.	LYY	Class I	1989-09-01
K892020	Patient Examination Gloves (Latex)	Asset Ent., Sdn Bhd	LYY	Class I	1989-09-01
K891831	Patient Examination Gloves (Latex)	Pai Hoi Ent., Ltd.	LYY	Class I	1989-09-01
K891744	Surgimax Patient Exam Gloves (Latex)	Excel Rubber Products (M) Sdn. Bhd.	LYY	Class I	1989-09-01
K891173	Osteograf/p Periodontal Hydroxylapatite, 40-60	Ceramed Corp.	LYC	Class II	1989-09-01