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 2604 of 3530

510(k) clearances, page 2604 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K884715	Achelasia Balloon Dialator	Primrose Medical, Inc.	KNQ	Class II	1989-09-29
K884714	Biliary Dialator	Primrose Medical, Inc.	FGE	Class II	1989-09-29
K884713	Colonic Balloon Dialators	Primrose Medical, Inc.	FFP	Class I	1989-09-29
K884711	Urethral and Ureteral Balloon Dilatators	Primrose Medical, Inc.	EZN	Class II	1989-09-29
K895570	Valproic Acid (Fpia) Calibrator Kit	Tudor Laboratories, Inc.	DLJ	Class II	1989-09-28
K895568	Primidone (Fpia) Calibrator Kit	Tudor Laboratories, Inc.	DLJ	Class II	1989-09-28
K895398	Bio-Coordinator System	Bio-Harmonizer, Inc.	IKK	Class II	1989-09-28
K895353	Opsite i.v. 3000	Smith & Nephew United, Inc.	KGX	Class I	1989-09-28
K895207	Bioclusive* Transparent Film Dressing - New Claim	Johnson & Johnson International	FRO	Unclassified	1989-09-28
K895004	Milenia(tm) Total Ige (Mkie1,5)	Siemens Healthcare Diagnostics Inc.	DGC	Class II	1989-09-28
K894996	Exusorb(tm) Granules	Controlled Therapeutics Corp.	FRO	Unclassified	1989-09-28
K894962	CO2 Laser Bronchoscope Coupler	Cuda Products Co.	GEX	Class II	1989-09-28
K894852	Serachem Plus Clinical Chemistry Controls	Instrumentation Laboratory Co.	JJY	Class I	1989-09-28
K894804	Single (Specified) Analyte Control (Assayed)	Lifescan, Inc.	JJX	Class I	1989-09-28
K894765	Sharplan Smoke Evacuation Unit, Model 100	Laser Industries, Ltd.	FYD	Class II	1989-09-28
K894524	Fpr Gentamicin Calibrator Kit	Colony Laboratories, Inc.	DLG	Class I	1989-09-28
K894523	Fpr Gentamicin Kit	Colony Laboratories, Inc.	LCQ	Class II	1989-09-28
K894518	Fpr Amikacin Calibrator Kit	Colony Laboratories, Inc.	DLG	Class I	1989-09-28
K894517	Fpr Amikacin Kit	Colony Laboratories, Inc.	KLQ	Class II	1989-09-28
K894374	Blood Drawing Needle	Pharma-Plast USA, Inc.	FMI	Class II	1989-09-28
K894372	Nipro Needle Holder	Pharma-Plast USA, Inc.	FMI	Class II	1989-09-28
K894310	Amresco Triglycerides Reagents (Products 7730)	American Research Products Co.	CDT	Class I	1989-09-28
K894222	Tdxr Analyzer with Lites Tm Lithium Carousel	Abbott Medical	JJE	Class I	1989-09-28
K894221	Rosco Pyrr	Pro-Lab, Inc.	JTO	Class I	1989-09-28
K894193	Latex Examination Gloves	Hasil Getah Gulungan Pertama	LYY	Class I	1989-09-28
K894160	Hand Tools for Artech Type Ss Submerged Screw Impl	Artech Corp.	DZE	Class II	1989-09-28
K894157	Obturator	Argon Medical Corp.	DYB	Class II	1989-09-28
K894129	Biliblanket Phototherapy Device	GE Healthcare	LBI	Class II	1989-09-28
K894111	Vari-Set	Sonex Medical	LDR	Class II	1989-09-28
K894105	Target Therapeutics Tracker Lf Catheter	Target Therapeutics	DQY	Class II	1989-09-28
K894038	Plume-Away Smoke Evacuation System	Laser Technologies Group, Inc.	FYD	Class II	1989-09-28
K893843	Ez-Bead Digoxin Eia Kit	IMMUNOTECH s.r.o.	KXT	Class II	1989-09-28
K893718	Deltatest (R) Lipase II	Electro-Nucleonics, Inc.	CET	Class I	1989-09-28
K893682	Kit- Ciba Corning L-Tdm I, II, III	Ciba Corning Diagnostics Corp.	DIF	Class I	1989-09-28
K892904	Mitek Drill Guide	Mitek Surgical Products, Inc.	HXY	Class I	1989-09-28
K892655	Acl Drill Guide System	Baxter Healthcare Corporation	LXI	Class I	1989-09-28
K892586	Patient Examination Gloves (Latex)	Modlook Industries, Ltd.	LYY	Class I	1989-09-28
K891605	Coat-a-Count(tm) Fentanyl (Tkfn1)	Siemens Healthcare Diagnostics Inc.	DJG	Class II	1989-09-28
K891588	Tri-Lumen Intra Vascular Balloon Catheter (Gu Use)	Ideal Medical, Inc.	LQR	Class II	1989-09-28
K895670	Surgical Suction Apparatus	Baker-Sundt Research, Inc.	GEA	Class I	1989-09-27
K895598	Wako(tm) Autokit Crp	FUJIFILM Healthcare Americas Corporation	DCK	Class II	1989-09-27
K895369	Voss Graft Marker	voss medical products	KPK	Class II	1989-09-27
K895277	Ortho Apo B Elisa Test System	Medical Marketing Consultants, Inc.	MSJ	Class I	1989-09-27
K895258	Latex Patient Examination Gloves	Perfect Treasure Development, Ltd.	LYY	Class I	1989-09-27
K895212	Tik Extraktor	Instruments of Sweden, Inc.	HTD	Class I	1989-09-27
K895109	Secondary IV Set with Protected Needle	Kendall Mcgaw Laboratories, Inc.	FPA	Class II	1989-09-27
K895042	Sharplan CO2 Lasers for Arthroscopic Surgery	Sharplan Lasers, Inc.	GEX	Class II	1989-09-27
K894487	Ivac(r) Volumetric Controller - Model 262+	Y	LDR	Class II	1989-09-27
K894414	Hearing Aid (in-the-Canal)	Hearing Aid Express	ESD	Class I	1989-09-27
K894298	Modified Gemini Acetabular Cup	Depuy, Inc.	JDI	Class II	1989-09-27