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 2706 of 3530

510(k) clearances, page 2706 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K881320	Urine Toxicology Standard	Verichem Laboratories, Inc.	DKB	Class II	1988-09-09
K883160	Catapult Bucky (Katapult Blenda)	Bay X-Ray, Inc.	KPR	Class II	1988-09-08
K883096	Tracheal Tube Laser Shield Kit	Americal Corp.	BTR	Class II	1988-09-08
K882737	Acuson I7505 Transducer, Ultrasound Transducer	Acuson Corp.	IYN	Class II	1988-09-08
K882552	Metatech Robinson Bolt Accessory	Metatech Corp.	GWM	Class II	1988-09-08
K882477	Addit. Data for Breakpoint/id Gram-Neg. Panel	Pasco Laboratories, Inc.	JWY	Class II	1988-09-08
K882451	Olympus Reply Chemistry Analyzer	Olympus Corp.	JJE	Class I	1988-09-08
K882015	Transcran(tm) Transcranial Pulsed Doppler System	Ultramed, Inc.	IYN	Class II	1988-09-08
K881701	Radkor Sfc-21	Radkor, Inc.	IYB	Class I	1988-09-08
K881519	Vac-G (Guillotine Vitrector)	B&B Medical Assoc., Inc.	HQE	Class II	1988-09-08
K881412	Myocard Biopsy Forcep	Fehling Medizintechnik GmbH	DWZ	Class II	1988-09-08
K883632	Ex-Cell 300Tm, Catalog No. 210-3575	J R Scientific	KIT	Class I	1988-09-07
K883631	Ex-Cell 300Tm, Catalog # 210-3579	J R Scientific	KIT	Class I	1988-09-07
K883630	Rpmi-1640 Medium, Catalog No. 210-3525	J R Scientific	KIT	Class I	1988-09-07
K883629	Hank's Balanced Salts (Hbss) Catalog # 210-3013	J R Scientific	KIT	Class I	1988-09-07
K883628	Min Essent Med Eagle for Spinn Culture, #200-2051	J R Scientific	KIT	Class I	1988-09-07
K883627	Min Essent Med Eagle, Joklik Mod, Cat. #200-2150	J R Scientific	KIT	Class I	1988-09-07
K883626	Ex-Cell 301, Catalog No. 210-3577	J R Scientific	KIT	Class I	1988-09-07
K883625	Ex-Cell 301, Catalog No. 200-3651	J R Scientific	KIT	Class I	1988-09-07
K883624	Ex-Cell 300Tm, Catalog No. 200-3601	J R Scientific	KIT	Class I	1988-09-07
K883623	Ex-Cell 300Tm, Catalog No. 200-3600	J R Scientific	KIT	Class I	1988-09-07
K883538	Qm300 Calibrator E Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DHR	Class II	1988-09-07
K883536	Qm300 Rheumatoid Factor Antigen Pack	Kallestad Diag, A Div. of Erbamont, Inc.	DHR	Class II	1988-09-07
K883494	Technicon Dpa-1 Immunoglobulin G	Technicon Instruments Corp.	DAH	Class II	1988-09-07
K883491	Technicon Dpa-1 Apolipoprotein B	Technicon Instruments Corp.	MSJ	Class I	1988-09-07
K883394	Gram Negative and Gram Positive Mic/combo Panels	Baxter Healthcare Corporation	JWY	Class II	1988-09-07
K883385	Resubmitted Utiscreen(tm) Bacterial Atp Test	Los Alamos Diagnostics	JXA	Class I	1988-09-07
K883355	Ubi Magiwel RF-Igm Quantitative	United Biotech	DHR	Class II	1988-09-07
K883349	Qlia Immunochemistry System	BD Becton Dickinson Vacutainer Systems Preanalytic	JZT	Class I	1988-09-07
K883273	Dhbti-Allergen Ige Fastscreen IV (G1,g5,g12,g13)	3M Company	DHB	Class II	1988-09-07
K883232	Histone Reactive Ana	Val Tech Diagnostics, Inc.	LLL	Class II	1988-09-07
K883076	Gram Negative & Gram Positive Mic/combo Panels	Baxter Healthcare Corporation	JWY	Class II	1988-09-07
K882998	Acute Phase C-Reactive Protein Latex Agglu. Test	Amtec Diagnostics International, Inc.	DCK	Class II	1988-09-07
K882612	System 9000 Diff Model Automated Cell Counter	Baker Instructions Corp.	GKZ	Class II	1988-09-07
K882579	Hematrak(r) Model 590	Priority Service Systems	GKZ	Class II	1988-09-07
K881520	Vac (Oscillating Vitrector)	B&B Medical Assoc., Inc.	HQE	Class II	1988-09-07
K880973	Microlyte 7	The Rupp & Bowman Co.	JFP	Class II	1988-09-07
K883602	Biopore Vs.1 Endocardial Inter Implant Pacing Lead	Intermedics, Inc.	DTB	Class III	1988-09-06
K883512	Heraeus White	Degussa Dental, Inc.	EJS	Class II	1988-09-06
K883424	Surgical Gown/scrub/laparotomy/mayo Stand/back Tab	Intera Corp.	KKX	Class II	1988-09-06
K883203	Model 5866-34A Pacemaker Lead Adaptor	Medtronic, Inc.	DTB	Class III	1988-09-06
K883162	Telestatix X-Ray Table	Bay X-Ray, Inc.	IXR	Class II	1988-09-06
K883155	Rastix X-Ray Table	Bay X-Ray, Inc.	KXJ	Class II	1988-09-06
K883154	Seldix 325 Two Pulse Generator/control	Bay X-Ray, Inc.	IZO	Class I	1988-09-06
K883153	Undistat with Explorator 35 (Ucs 35E)	Bay X-Ray, Inc.	IXR	Class II	1988-09-06
K882442	Rk2000 K-Thermia System	Baxter Healthcare Corporation	DWJ	Class II	1988-09-06
K882422	Disposable Arachnoid Knife	Microbio-Medics, Inc.	HAO	Class I	1988-09-06
K882407	Bow & Arrow Drill Guide	Instrument Makar, Inc.	LXI	Class I	1988-09-06
K882330	Bard Baim-Turi Balloon Diagnostic Pacing Catheter	C.R. Bard Inc	LDF	Class II	1988-09-06
K882145	Photo-Curing Light	Dentsply Intl.	EBZ	Class II	1988-09-06