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 2885 of 3529

510(k) clearances, page 2885 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K862262	Hcg Maiaclone Immunoradiometric Kit/kit Components	Serono Diagnostics, Inc.	JHI	Class II	1986-07-29
K862255	Lactate Dehydrogenase (Ldh) Reagent Set (UV Rate)	Sterling Diagnostics, Inc.	CFJ	Class II	1986-07-29
K862253	Il 482 Co-Oximeter	Instrumentation Laboratory Co.	JKS	Class I	1986-07-29
K862247	Target Hcg, Enzyme Immunoassay Reagents	V-Tech, Inc.	JHI	Class II	1986-07-29
K862232	Panavia Tc, and Panavia Opaque	Kuraray Co.	EBF	Class II	1986-07-29
K862061	Osteograf/ar+ Permaridge Hydroxylapatite, 18-40	Coors Biomedical Co.	LYC	Class II	1986-07-29
K861792	Twin Got-Ast Ifcc/gpt-Alt Ifcc	Boehringer Mannheim Corp.	CKA	Class I	1986-07-29
K861786	Du Pont Drug Calibrator	E.I. Dupont de Nemours & Co., Inc.	JIX	Class II	1986-07-29
K861703	Leeco Concep-7-Bhcg (Eia) II (Modified)	Leeco Diagnostics, Inc.	JHJ	Class II	1986-07-29
K860766	Millar Pulsed Doppler Velocimeter	Millar LLC.	DPW	Class II	1986-07-29
K860538	Right-Day Urinary Lh (Eia)	Leeco Diagnostics, Inc.	CEP	Class I	1986-07-29
K862691	Stopcock	Ram Development	FMG	Class II	1986-07-28
K862380	Mattress Cover	Intera Corp.	EYQ	Class I	1986-07-28
K862194	Inhalator Models 8100, 10100 and 10200	U.O. Equipment Co.	CAW	Class II	1986-07-28
K861026	Liban Intubator	Life Support Devices Co.	CCW	Class I	1986-07-28
K862482	Steinhauser Titanium Mini Bone Plates & Screws	Biomet Microfixation	JEY	Class II	1986-07-25
K862311	Screw Driver/bone Screw Wrench/tap & Guide Pin	Warsaw Orthopedic, Inc.	KTT	Class II	1986-07-25
K862279	Expendaguide Multiple Hip Pinning Guide System	Orthospec, Inc.	KTW	Class II	1986-07-25
K861942	Collimator Model A280ble & Model A280-Blm	D&R X-Ray Products, Inc.	IZW	Class II	1986-07-25
K861941	Collimator Model A280blmd & Model A280blmp	D&R X-Ray Products, Inc.	IZX	Class II	1986-07-25
K861733	Additional Kyotest Urine Test Reagent Strips	Kyoto Diagnostics, Inc.	JIL	Class II	1986-07-25
K861456	Sheets Lyophilized Collagen Heyedrator	Pantheon Products, Inc.	HMP	Class I	1986-07-25
K861429	Digitron 3V,3va,3vac,3 High Resolution Upgrade	Siemens Gammasonics, Inc.	LLZ	Class II	1986-07-25
K861173	Optilase Yag Model 1000 Surg Laser System/gastro	Trimedyne, Inc.	LNK	Class II	1986-07-25
K860163	Bicondylar Toe Prosthesis	Depuy, Inc.			1986-07-25
K862730	Danniflex 400Sl	Danninger Medical Technology, Inc.	BXB	Class I	1986-07-24
K862335	Modified i.v. Start, Re-Start, Pedi and Geri-Kit	U.S. Mfg. & Management, Inc.			1986-07-24
K862159	Acuson S319 Transducer	Acuson Computed Sonography	JOP	Class II	1986-07-24
K861737	Meridian Imaging System	Johnson & Johnson Professionals, Inc.	JOP	Class II	1986-07-24
K861598	Intelligraph(tm) Programmer	Intelligent Medicine, Inc.	FRN	Class II	1986-07-24
K861266	Howmedica Kinematic Plus Knee System	Howmedica Corp.	JWH	Class II	1986-07-24
K860697	Ultrasound Imaging System Model 280 Sl	Johnson & Johnson Professionals, Inc.	IYO	Class II	1986-07-24
K862658	Concept Arthroscopic Knife	Concept, Inc.	HRX	Class II	1986-07-23
K862657	Concept Curette	Concept, Inc.	HRX	Class II	1986-07-23
K862611	Sterile Disposable Trocar-Sleeve Devices	United States Surgical, A Division of Tyco Healthc	GCJ	Class II	1986-07-23
K862597	Various Surgical Instruments	Konig W.G., Ltd.	GAD	Class I	1986-07-23
K862578	Techna Vision Casting Resin	Techna Vision	HQG	Class I	1986-07-23
K862577	Linen (Huck) Towel	Dimed, Intl.	KKX	Class II	1986-07-23
K862519	Bausch & Lomb Accu-Chart 3 Acuity Projector	Bausch & Lomb Incorporated	HOS	Class I	1986-07-23
K862509	Charcoal Laser Smoke Filter Catalog No. 901103-000	Lifestream Int'L, Inc.	JDY	Class I	1986-07-23
K862481	Civco/kempf Aspiration/biopsy/dialysis Needle	CIVCO Medical Instruments Co., Inc.	GDM	Class I	1986-07-23
K862404	Reflex(tm) Clip Applier	Richard-Allan Medical Ind., Inc.	FZP	Class II	1986-07-23
K862376	Nemectroson Model 2	Nemectron Medical, Inc.	IMJ	Class II	1986-07-23
K862203	Mcghan Magna-Site(tm) Tissue Expander	Mcghan Medical Corp.	LCJ	Unclassified	1986-07-23
K862137	Nidek Km-1000 Surgical Keratometer	Nidek, Inc.	HLQ	Class I	1986-07-23
K861742	Electro-Surgical Pencils	Stryker Corp.	GEI	Class II	1986-07-23
K861299	Hygienic Air Purifying Device	Puridyne, Inc./Imutech, Inc.	FRF	Class II	1986-07-23
K860892	Clinagel (Absorbent Gel)	Schering Chemicals, C/O Ellis Pharmaceuticals	FRO	Unclassified	1986-07-23
K862693	Toray Filtryzer Dialyzer, B1-2.0.	National Medical Care, Medical Products Div., Inc.	FJI	Class II	1986-07-22
K862590	3M Esthetic Design System (Tints & Masking Agents)	3M Company	EBD	Class II	1986-07-22