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 2026-10-26, 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 2775 of 3530

510(k) clearances, page 2775 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K874145	Titan Gel Rep Ldh-6 Hv	Helena Laboratories, Corp.	CFE	Class II	1987-11-24
K874142	Titan Gel Rep Ldh-30 Hv	Helena Laboratories, Corp.	CFE	Class II	1987-11-24
K874105	Brachial Plexus Catheter - Bp-01200	Arrow Intl., Inc.	CAZ	Class II	1987-11-24
K873987	Iras Glare Tester	Randwal Instrument Co., Inc.	HLJ	Class II	1987-11-24
K873895	Hot Wheels	Everest & Jennings, Inc.	ITI	Class II	1987-11-24
K873875	Baxa Exacta-Med Pharmacy Pump	Baxa Corp., Sub. of Cook Group, Inc.	FRN	Class II	1987-11-24
K873835	Glucose-Hk Reagent	Intersect Systems, Inc.	CFR	Class II	1987-11-24
K873768	Humid-Vent(r) 2 Port	Gibeck Respiration	BYD	Class I	1987-11-24
K873737	No Spin(tm) T3 Coated Tube Radioimmunoassay	Cambridge Medical Technology	CDP	Class II	1987-11-24
K873499	Todd Medical/skilled Care Products	Todd Medical, Inc.	BTO	Class II	1987-11-24
K873298	Elec-Tip	Etymotic Research, Inc.	GXY	Class II	1987-11-24
K874535	Microtek Mini-Max Drill System	Microtek Medical LLC	DZI	Class II	1987-11-23
K874494	Kambin Laminectomy Frame	Avec Scientific Design Corp.	LWG	Class I	1987-11-23
K874489	Revised Labeling for Tdx Benzodiazepines	Abbott Medical	JXM	Class II	1987-11-23
K874488	Revised Labeling for Tdx Cannabinoids	Abbott Medical	LDJ	Class II	1987-11-23
K874487	Revised Labeling for Tdx Cocaine Metabolite	Abbott Medical	DIO	Class II	1987-11-23
K874486	Revised Labeling for Tdx Amphetamine/methampheta.	Abbott Medical	DKZ	Class II	1987-11-23
K874485	Revised Labeling for Opiates	Abbott Medical	DJG	Class II	1987-11-23
K874484	Revised Labeling for Tdx Phencyclidine	Abbott Medical	LCL	Unclassified	1987-11-23
K874483	Revised Labeling for Tdx Barbiturates	Abbott Medical	DIS	Class II	1987-11-23
K874477	Easy-Test Urea Nitrogen (Bun) Item Number: 19010	Em Diagnostic Systems, Inc.	CDQ	Class II	1987-11-23
K874435	Bicarbonate	Boehringer Mannheim Corp.	KHS	Class II	1987-11-23
K874394	Quantum(r) Models 253-19V & 254-20V Pulse Genera.	Intermedics, Inc.	DXY	Class III	1987-11-23
K874376	Revised Labeling for Syva Benzodiazepine Assays	Syva Co.	JXM	Class II	1987-11-23
K874359	Adjustable Wrenches	Med-Tool, Inc.	HXC	Class I	1987-11-23
K874358	Combination Wrenches	Med-Tool, Inc.	HXC	Class I	1987-11-23
K874357	Tapered Punch	Med-Tool, Inc.	LRY	Class I	1987-11-23
K874356	Pin Punch	Med-Tool, Inc.	LRY	Class I	1987-11-23
K874352	Tumorimeter	Cancer Technologies, Inc.	FTY	Class I	1987-11-23
K874327	Skin Prep Analyzer	Marquette Electronics, Inc.	KRC	Class II	1987-11-23
K874299	N-Tact Pth by Immunoradiometric Assay (Irma)	Incstar Corp.	CEW	Class II	1987-11-23
K874263	Wako(tm) Fe C	FUJIFILM Healthcare Americas Corporation	JIY	Class I	1987-11-23
K874258	Ventrescreen, Hcg Urine	Ventrex Laboratories, Inc.	JHI	Class II	1987-11-23
K874246	Iron Horse One	Iron Horse Productions, Inc.	IOR	Class I	1987-11-23
K874230	Precinorm L	Boehringer Mannheim Corp.	JJY	Class I	1987-11-23
K874219	S3 Medicated Gauze	Surgical Specialties Corp	FRO	Unclassified	1987-11-23
K874163	Albumin (Bcg) for Continuous Flow Instruments	Catachem, Inc.	CIX	Class II	1987-11-23
K874159	Patient Temperature Monitor, Model 1000	Sonodyne America, Ltd.	FLL	Class II	1987-11-23
K874155	Circamed Monitor Remote Start Conductance Meter	Circadian, Inc.	KRC	Class II	1987-11-23
K874144	Titan Gel Rep Cpk-6 Hv	Helena Laboratories, Corp.	JHX	Class II	1987-11-23
K874143	Titan Gel Rep Ldh-12 Hv	Helena Laboratories, Corp.	CFE	Class II	1987-11-23
K874091	360D Dc Defibrillator	Medac, Inc.	LDD	Class II	1987-11-23
K874053	Inflatable Full Arm Splint	Vinyl Technology, Inc.	FZF	Class I	1987-11-23
K874052	Inflatable Half Leg Splint	Vinyl Technology, Inc.	FZF	Class I	1987-11-23
K874051	Inflatable Full Leg Splint	Vinyl Technology, Inc.	FZF	Class I	1987-11-23
K874050	Inflatable Foot & Ankle Splint	Vinyl Technology, Inc.	FZF	Class I	1987-11-23
K874040	Mamex Dc S Sl10/mg14	Orion Corp.	IZH	Class II	1987-11-23
K874024	Acu-Micro-Needle	Acuderm, Inc.	FMI	Class II	1987-11-23
K873978	Disposable Bipolar Forceps	E.M. Adams Co., Inc.	GEN	Class I	1987-11-23
K873945	Ciba Corning Magic Lite T3 Immunoassay	Ciba Corning Diagnostics Corp.	CDP	Class II	1987-11-23