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 2736 of 3530

510(k) clearances, page 2736 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K880681	Mini-Filter, Virobac II	King Systems Corporation.	CAH	Class II	1988-04-29
K875365	Model 200A Infusion Pump	Avi, Inc.	FRN	Class II	1988-04-29
K875348	Model 400A Infusion Pump	Avi, Inc.	FRN	Class II	1988-04-29
K875347	Model 210A Infusion Pump	Avi, Inc.	FRN	Class II	1988-04-29
K875266	Ssh-160A Ultrasonic Pulsed Echo Imaging System	Toshiba Medical Systems	DPT	Class II	1988-04-29
K874154	Elecath(r) Transesophageal Pacing Catheter	Electro-Catheter Corp.	KNT	Class II	1988-04-29
K873398	Exl-22Dp X-Ray Radiation Therapy System	Mitsubishi Intl. Corp.	IYE	Class II	1988-04-29
K881439	Modified Utiscreen(tm) Bacterial Atp Test System	Los Alamos Diagnostics	JXA	Class I	1988-04-28
K881400	Creatinine for Continuous Flow Instruments	Catachem, Inc.	CGX	Class II	1988-04-28
K881395	Gauze and Lap Sponges -Sterile & Non-Sterile	A Plus International, Inc	EFQ	Unclassified	1988-04-28
K881311	Biotrol -Gt Gamma-Glutamyl Transferase (Ggt) Test	Biotrol, USA, Inc.	JQB	Class I	1988-04-28
K881302	Duoderm(r) Hydroactive(r) Paste	Convatec, A Division of E.R. Squibb & Sons	FRO	Unclassified	1988-04-28
K881240	Chloride Reagent Set	Tech-Neal Scientific, Inc.	CHJ	Class II	1988-04-28
K881237	Creatine Kinase (Ck) Reagent Set	Tech-Neal Scientific, Inc.	JHX	Class II	1988-04-28
K881204	Acp Kinetic Test (Acid Phosphatase Test)	Sclavo, Inc.	CKB	Class II	1988-04-28
K881202	Iron Test	Sclavo, Inc.	JIY	Class I	1988-04-28
K881200	Chloride Liquid Stable Reagent Set	Medical Analysis Systems, Inc.	CHJ	Class II	1988-04-28
K881171	Phosphorus (Inorganic)	Tech-Co, Inc.	CEO	Class I	1988-04-28
K881169	Carbon Dioxide Reagent	Intersect Systems, Inc.	KHS	Class II	1988-04-28
K881167	Iron Procedure	Data Medical Associates, Inc.	JIY	Class I	1988-04-28
K881166	Direct Bilirubin Procedure	Data Medical Associates, Inc.	CIG	Class II	1988-04-28
K881123	Allegro(tm) Follicle Stimulating Hormone Immuno.	Nichols Institute Diagnostics	CGJ	Class I	1988-04-28
K881104	Paramax Iron Reagent	Baxter Healthcare Corporation	JIY	Class I	1988-04-28
K880967	Micro CO2 Apparatus	Hf Scientific, Inc.	CIE	Class II	1988-04-28
K880866	Carbon Dioxide Assay Kit(enzy. Single) 203-10	Diagnostic Chemicals, Ltd. (USA)	KHS	Class II	1988-04-28
K880594	Vacuguard(tm)	Habley Medical Technology Corp.	JKA	Class II	1988-04-28
K880493	Medrad Microprocessor CT Injection System	Medrad, Inc.	DXT	Class II	1988-04-28
K880478	Pregnancy Beta-Hcg Card & Liquid Test	Ampcor, Inc.	JHJ	Class II	1988-04-28
K880451	Scimed Models P-7-14 and a-19-38 Heat Exchangers	Scimed Life Systems, Inc.	DTR	Class II	1988-04-28
K880421	Descending Arch Cannula	Dlp, Inc.	DWF	Class II	1988-04-28
K880237	Cholesterol	Tech-Neal Scientific, Inc.	CHH	Class I	1988-04-28
K874909	Micro-Bumintest Reagent Tablets	Miles Laboratories, Inc.	JIR	Class I	1988-04-28
K874202	Acs Hi-Torque Guide Wires	Advanced Cardiovascular Systems, Inc.	DQX	Class II	1988-04-28
K873577	Gem-Stat, Gem-Pak 2, Gem-Check, Gem-Crit Check	Diamond Sensor Systems	CHL	Class II	1988-04-28
K881699	Acromed Washers	Buckman Co., Inc.	HTN	Class II	1988-04-27
K881591	A2j Mz 45 Laser Light for Positioning	A2j, Inc.	IWX	Class I	1988-04-27
K881502	Brewer Gel for Campylobacter	Fairleigh Dickinson Laboratories, Inc.	KZJ	Class I	1988-04-27
K881500	Ortho* Chlamydia Direct Detection (Fa) Test	Ortho Diagnostic Systems, Inc.	LJP	Class I	1988-04-27
K881332	Diaflex Grasp Forceps/retrieval Loop & Cyto Brush	Baxter Healthcare Corporation	OCZ	Class II	1988-04-27
K881290	Modified Shiley Dual Lumen Subclavian Cannula	Shiley, Inc.	LFJ	Class II	1988-04-27
K881137	Vapor-Phase Heated Wire Controller	Advanced Research Technologies, Inc.	BZE	Class II	1988-04-27
K881028	7.5 Mhz Endorectal Probe	Philips North America LLC	IYO	Class II	1988-04-27
K880958	Lifeguard Bacterial and Viral Filter	Lifeguard Medical Products, Inc.	CAH	Class II	1988-04-27
K880753	Umbilical Cord Clamp	I M, Inc.	HFW	Class II	1988-04-27
K880745	Lx-100 Slide Stainer	Innovative Medical Systems, Inc.	KPA	Class I	1988-04-27
K880700	Enzygnost(r) Tat Reagents	Behring Diagnostics, Inc.	JBQ	Class II	1988-04-27
K880391	Dacomed Cystometer	Dacomed Corp.	EXQ	Class II	1988-04-27
K880209	Periodontal Probe - Autoprobe	Dentsply Intl.	EIL	Class I	1988-04-27
K874084	Multiple Artificial Kidney Systems (Maks) #Idm	National Medical Care, Medical Products Div., Inc.	FKQ	Class II	1988-04-27
K873947	Bio-EMG Model 800	Bio-Research Associates, Inc.	KZM	Class II	1988-04-27