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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2306 of 3531

510(k) clearances, page 2306 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K924160	Hybrid Surgical Device	Lca, Inc.	GEX	Class II	1993-04-23
K923667	Irrigation/suction Probe	Surgical Instrument, Inc.	GBX	Class I	1993-04-23
K922987	Lapstick Laparoscopic Sponge Stick/ Blunt Dissec.	Biosearch Medical Products, Inc.	GCJ	Class II	1993-04-23
K922319	Omni Laparoscope	Expanded Optics, Inc.	GCJ	Class II	1993-04-23
K921766	Ohio Infant Warmer System	GE Healthcare	FMT	Class II	1993-04-23
K920736	Ivex-Hp96 Extended Life Filter Set	Abbott Medical	FPB	Class II	1993-04-23
K930874	Ld-1 Control-Level 1 & 2	Cala Diagnostics	JJX	Class I	1993-04-22
K925935	Olympus Reply Clinical Chemistry Analyzer	Olympus Corp.	JJQ	Class I	1993-04-22
K924607	Arrow Fischell Kink Resist Percut Sheath Intro Set	Arrow Intl., Inc.	DYB	Class II	1993-04-22
K931105	Procheck(tm) Blind Performance Specimens	Dynagen, Inc.	DIF	Class I	1993-04-21
K930898	Radias Automated Immunoassay System	Bio-Rad	JJI	Class I	1993-04-21
K930479	Nylex Catheters	Cordis US Corp.	DQO	Class II	1993-04-21
K930451	Prospec T Giardia Microtiter Assay	Alexon, Inc.	MHI	Class II	1993-04-21
K930225	K-Lok Catheter Securement Device	K-Lok, Inc.	KMK	Class I	1993-04-21
K930166	Iron Test #'S 42376/93,42324/R1a,42324/r1b,42324/r	Em Diagnostic Systems, Inc.	JIY	Class I	1993-04-21
K930083	Ems Biopsy Instrument	Engineered Medical Systems, LLC	KNW	Class II	1993-04-21
K925384	Isopore(tm) Tape, Modification	Lectec Corp.	KGX	Class I	1993-04-21
K924671	Baxter Adult/pedi Infant Single/use Man Resuscit	Engineered Medical Systems, LLC	BTM	Class II	1993-04-21
K924226	Ojemann Cortical Stimulator	Radionics, Inc.	GYC	Class II	1993-04-21
K924064	Interlink Universal Vial Adapter	Baxter Healthcare Corporation	LHI	Class II	1993-04-21
K923470	Disposable Hot Biopsy Forceps	Wilson-Cook Medical Inc.	KGE	Class II	1993-04-21
K923019	Pharmacia Deltec Winged Infusion Set	Pharmacia Deltec, Inc.	LJT	Class II	1993-04-21
K922221	Sprint Dx, Model 5400 Exercise Stress Test System	Del Mar Avionics	LOS		1993-04-21
K921168	Allen Infusion Pump Model 3000 and Irrigation 2000	Allen Medical Systems, Inc.	KZD	Class I	1993-04-21
K931050	Cardio Rep Ck Isoenzyme Kit - 3310	Helena Laboratories, Corp.	JHW	Class II	1993-04-20
K930989	Pulpdent Unfilled Dual Cure Bonding Resin	Pulpdent Corporation	KLE	Class II	1993-04-20
K930849	Verify Reference Plasma and Mda Verify Ref. Plasma	bioMerieux, Inc.	JPA	Class II	1993-04-20
K930845	Roche Abuscreen Ontrak for Methadone	Roche Diagnostic Systems, Inc.	DIW	Class II	1993-04-20
K930569	Laparomed Laparoscopic Retractor System	Laparomed Corp.	GCJ	Class II	1993-04-20
K930496	Gi-1090,1095,1080,1085,1086,1088, Endo. Clamps	Birtcher Medical Systems, Inc.	GCI	Class II	1993-04-20
K930241	Olympus Disposable Biopsy Forceps	Olympus Corp.	KNW	Class II	1993-04-20
K930208	Cholinesterase Method for Technicon Chem1/technico	Kulzer GmbH	DLI	Class I	1993-04-20
K930197	Kwik Board	Astral, Ltd.	KMK	Class I	1993-04-20
K926290	Burn Sheet	Gam Industries, Inc.	FPY	Class I	1993-04-20
K926264	Medicotest Skin Fix	Medicotest, Inc.	KGX	Class I	1993-04-20
K926223	Endoscope and Accessories	Weck Endoscopy	GCJ	Class II	1993-04-20
K926199	Uniclip Surgical Clip Applier	Unisurge, Inc.	GDO	Class I	1993-04-20
K926034	Epi-Lock Wound Dressing	Calgon Vestal Div.	MGP	Unclassified	1993-04-20
K925949	Pedicragt Bassinet	Pedicraft, Inc.	FMS	Class II	1993-04-20
K925842	Becton Dickinson Simultrac Component System	BD Becton Dickinson Vacutainer Systems Preanalytic	CEC	Class II	1993-04-20
K925817	Head & Foot End Drop Pedi-Crib	Pedicraft, Inc.	FMS	Class II	1993-04-20
K925779	Branemark System Titanium Healing Abutments	Nobelpharma USA, Inc.	NHA	Class II	1993-04-20
K925708	Disposable Electrosurgery Ball Electrode	Beacon Laboratories, Inc.	DWG	Class II	1993-04-20
K925695	Omnifit Zirconia C-Taper Femoral Bearing Head	Osteonics Corp.	LZO	Class II	1993-04-20
K925660	Kti Transparent Wound Dressing	Kingston Technologies, Inc.	MGP	Unclassified	1993-04-20
K925612	Hi Chem Electrolyte Buffer	Hichem Diagnostics	JGS	Class II	1993-04-20
K925551	Hi Chem Glucose Reagent Kit, Product No. 88807	Hichem Diagnostics	CGA	Class II	1993-04-20
K925550	Hi Chem Bun Reagent Kit,product Number 88806	Hichem Diagnostics	CDS	Class II	1993-04-20
K925046	Pleur-Evac Cardiotomy Reservoir	Deknatel, Inc.	DTN	Class II	1993-04-20
K924976	Allkare(tm) Adhesive Remover Wipe	Convatec, A Division of E.R. Squibb & Sons	KOX	Class I	1993-04-20