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 2726 of 3530

510(k) clearances, page 2726 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K881856	Biotrol Creatinine H.p. Reagent	Biotrol, USA, Inc.	CGX	Class II	1988-06-16
K881656	Humid-Vent 2 S Flex	Gibeck Respiration	BYD	Class I	1988-06-16
K881646	Urological Catheter	Coeur Laboratories, Inc.	KOD	Class II	1988-06-16
K881514	Pristine Specimen Tube and Introducer System	Hall Laboratories, Inc.	BSK	Class II	1988-06-16
K881482	Veolar Ventilator	Hamilton Medical AG	CBK	Class II	1988-06-16
K881473	Sl01 Oxygen Analyzer	Salter Labs	CCL	Class II	1988-06-16
K881472	Sl02 Oxygen Analyzer	Salter Labs	CCL	Class II	1988-06-16
K881321	Blood/solution Set W/pressure Pump	Baxter Healthcare Corporation	FPA	Class II	1988-06-16
K881293	Sheridan Electrosurgery Protection Filter	Sheridan Catheter Corp.	BZT	Class II	1988-06-16
K881269	Omron Digital Blood Pressure Monitor Hem-701C	Omron Electronics, Inc.	DXN	Class II	1988-06-16
K880694	B. Cat Confirm	Scott Laboratories, Inc.	JTO	Class I	1988-06-16
K880454	At Ease Stress Pad	Hospital Specialty Co.	EYQ	Class I	1988-06-16
K880258	Witt Biomedical Vx-80	Invivo Corporation	DXG	Class II	1988-06-16
K874366	Encor Bipolar Act/fixa Lead W/por Sur Ele #329-201	Cordis Leads, Inc.	DTB	Class III	1988-06-16
K882268	Zinc Formalin Concentrate	Anatech, Ltd.	IGG	Class I	1988-06-15
K882166	Jedmed Micro Ccd Camera System	JEDMED Instrument Company	FWD	Class I	1988-06-15
K882132	Light, Surgical Accessories	Charles Polo & Co., Inc.	FTA	Class II	1988-06-15
K882128	Tecnol Tiger Paws Product Number 47705-010	Tecnol New Jersey Wound Care, Inc.	FXP	Class I	1988-06-15
K882112	Murse Retractor	Euro-American Marketing Group, Inc.	GAD	Class I	1988-06-15
K882028	Coverall Shield	Bfd, Inc.	FXX	Class II	1988-06-15
K882027	Combo-Shield	Bfd, Inc.	FXX	Class II	1988-06-15
K882026	Add-a-Shield	Bfd, Inc.	FXX	Class II	1988-06-15
K882013	Soft Tissue Biopsy Device	Ocean Medical Products, Ltd.	DWO	Class I	1988-06-15
K881938	Bicarbonate (CO2) Reagent-2 Vial	Trace Scientific, Ltd.	KHS	Class II	1988-06-15
K881937	Surgical Instruments	Far East Intl. Trading Corp.	HRQ	Class I	1988-06-15
K881797	Easy Washer II Microplate Washer	Slt Labinstruments, Inc.	JJQ	Class I	1988-06-15
K881671	Manan Tabar-Rothschild Galactography Kit	Manan Medical Devices	FMI	Class II	1988-06-15
K881638	Surgical Blade	Far East Intl. Trading Corp.	GES	Class I	1988-06-15
K881602	Omron Digital Blood Pressure Monitor Model Hem703c	Omron Tateisi Electronics Co.	DXN	Class II	1988-06-15
K881601	Omron Digital Blood Pressure Monitor Model Hem403c	Omron Tateisi Electronics Co.	DXN	Class II	1988-06-15
K881455	Embolectomy Catheter(modified)	Cathlab Corp.	DXE	Class II	1988-06-15
K881449	Edwards-Duromedics Leaflet Probe, Model 1116	Baxter Healthcare Corporation	LXN	Class I	1988-06-15
K880926	Biological Ohm Meter, Bes 200Z	Bioelectrical Sciences, Inc.	DSB	Class II	1988-06-15
K880696	Mx1002 Cable-Cal Tm	Medex, Inc.	DXG	Class II	1988-06-15
K880353	Ciba Corning Model 280 Ph/blood Gas System	Ciba Corning Diagnostics Corp.	GKR	Class II	1988-06-15
K874148	Monitron System	American Health Products, Inc.	DRT	Class II	1988-06-15
K881898	Modified Spq(tm) Test System for Apolipoprotein B	Atlantic Antibodies	MSJ	Class I	1988-06-14
K881420	Omni-Vent, Series D/mri	Stein-Gates Medical Equipment, Inc.	CBK	Class II	1988-06-14
K881414	Cervicath	Epcom Medical Systems, Inc.	HDR	Class II	1988-06-14
K881397	Sanaplast	Nebo Industries	KGX	Class I	1988-06-14
K881220	Endocyte, Disposable Endometrial Sampler	Laboratoire Ccd C/O Washington Regulatory Services	HFE	Class II	1988-06-14
K881149	Mucus Trap or Suction Trap	Ferguson Medical	KDQ	Class II	1988-06-14
K881129	Auto-Vac Intraoperative Autotrans. Reservoir #7904	Boehringer Laboratories, LLC	CAC	Class II	1988-06-14
K875110	House Dust; Hollister-Stier (H/s) Allergen Disc	Incstar Corp.	DHB	Class II	1988-06-14
K882126	Jel-5 Gold Based Alloys & Precious Metal Alloys	J.F. Jelenko & Co., Inc.	EJT	Class II	1988-06-13
K882098	Dentoridge(tm) Hydroxyylapatite	Norian Corp.	LYC	Class II	1988-06-13
K882063	Magne-Dent Magnet/zest Retrofit Keeper	Zest Anchors LLC	EGG	Class I	1988-06-13
K882006	Clearfil Photo Core	Kuraray Co.	EBF	Class II	1988-06-13
K881967	Cmi Vacuum Pump #001C - Vacuum Pump (Non-Electri.)	Challenge Mfg., Inc.	HDB	Class II	1988-06-13
K881924	Endosseous Dental Implant	Bone Anchorage Systems, Inc.	DZE	Class II	1988-06-13