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 2026-10-29, 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 2573 of 3530

510(k) clearances, page 2573 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K896203	Solcosept(tm) Blood Transfusion Filter	Solco Basle, Inc.	CAK	Class II	1990-02-01
K896125	Medipart Disposable Xenon-133 Rebreathing Mp-0133M	Medipart Jerry Alexander	IYT	Class II	1990-02-01
K895839	Pathodx Chlamydia Culture Confirmation Pkcc1	Siemens Healthcare Diagnostics Inc.	LJP	Class I	1990-02-01
K895799	Rectilinear Scanner Model #187-270	Atomic Products Corp.	IYW	Class I	1990-02-01
K895317	Avl Model 995Hb Ph/blood Gas Analyzer	Avl Scientific Corp.	CHL	Class II	1990-02-01
K894165	Theratron 1000	Theratronics, Inc.	IWB	Class II	1990-02-01
K893816	Hemolaser Hemoscope	Hemolaser Corp.	LYK	Class II	1990-02-01
K890294	Inter-Pal C-19 and Inter-Pal C-38	Enrad Corp.	JAQ	Class II	1990-02-01
K900272	Nka Models Ab-601G and Ab-621G	Nihon Kohden America Inc	DPS	Class II	1990-01-31
K900125	Arteriovenous Fistula Sets	Baxter Healthcare Corporation	FIE	Class II	1990-01-31
K896609	Cytoguide for Use W/the Philmedisyst Mammodiag Uc	Philips North America LLC	IZH	Class II	1990-01-31
K896581	Pediatric Drain Bag	Laytech Medical Co.	FFH	Class II	1990-01-31
K896421	Transparent Film i.v. Site/wound Dressing	Catalina Biomedical Corp.	KMK	Class I	1990-01-31
K896414	Venous Reservoir Bag Model No. Bmr-800 W/heparin	Baxter Healthcare Corporation	DTN	Class II	1990-01-31
K896337	Dental Bridge Anchoring Pins	Gayso Bridge-Tech, Inc.	EGG	Class I	1990-01-31
K895074	Angioscopy Pump	Baxter Healthcare Corporation	DQI	Class II	1990-01-31
K895036	Titanium Modular Modular Collarless Hip	Depuy, Inc.	JDI	Class II	1990-01-31
K895035	Titanium Modular Collared Hip Prosthesis	Depuy, Inc.	JDI	Class II	1990-01-31
K894937	Shaw Knee Modular Tibial Tray-Porous	Johnson & Johnson Professionals, Inc.	JWH	Class II	1990-01-31
K894802	Awc Butterfly Wound Closures	American White Cross, Inc.	FPX	Class I	1990-01-31
K900054	Kestrel Lens Case 1543-893S/p-1700-2611	Kestrel	LRX	Class II	1990-01-30
K900053	Kestrel Lens Case 731H-893S/p-1700-2611	Kestrel	LRX	Class II	1990-01-30
K900046	Novelty Graduation Sunglasses; Non-Prescription	Gibson Greetings, Inc.	HQY	Class I	1990-01-30
K896953	Modified Assess(r) Peak Flow Meter	Health Products, Inc.	BZH	Class II	1990-01-30
K896865	Vitro T4-Eia-Xt	In Vitro Diagnostics, Inc.	KLI	Class II	1990-01-30
K896678	Silicone Plug	Mizuho Orthopedic Systems Inc	HRX	Class II	1990-01-30
K896642	Modified Lh Enzyme Immunoassay Test Kit	Medix Biotech, Inc.	CEP	Class I	1990-01-30
K896603	Hsc Unit Rod	Danek Medical, Inc.	KWP	Class II	1990-01-30
K896505	Porges Universal Handles	Porges Corp.	GCP	Class II	1990-01-30
K896503	Porges Ercp Catheters	Porges Corp.	FGE	Class II	1990-01-30
K900017	Rep Glyco Control Normal(3209) and Abnormal(3210)	Helena Laboratories, Corp.	JPK	Class II	1990-01-29
K896965	Antimicrobial Susceptibility Test Panel	Alamar Biosciences Laboratory, Inc.	JWY	Class II	1990-01-29
K896573	Easi-Lav Adult Gastric Lavage Kit	Clairson Industries, LLC	KDH	Class II	1990-01-29
K896541	Malis Bipolar Electrosurgical System Cmc-III	Valley Forge Scientific Corp.	GEI	Class II	1990-01-29
K896507	Porges Diathermy Snare	Porges Corp.	KNS	Class II	1990-01-29
K896425	Porges Cytology Brushes	Porges Corp.	FDX	Class II	1990-01-29
K896325	Quantum Hip Stem	Depuy, Inc.	JDI	Class II	1990-01-29
K896296	Inpouch-Tv Pouch	Biomed Diagnostics, Inc.	JSN	Class I	1990-01-29
K896252	Modified Quinton Single Lumen Catheter	Quinton, Inc.	MPB	Class II	1990-01-29
K896032	Modified Elisa for Chlamydia	Fairleigh Dickinson Laboratories, Inc.	LJC	Class I	1990-01-29
K895673	Connection Shields Codes 5C4213 and 5C4215	Baxter Healthcare Corporation	KDJ	Class II	1990-01-29
K895631	Disconnect Caps Product Codes 5C4212 and 5C4466	Baxter Healthcare Corporation	KDJ	Class II	1990-01-29
K895483	Acme Coated Orthodontic Archwire	Acme-Monaco Corp.	EJF	Class I	1990-01-29
K895280	Clearview Chlamydia	Unipath, Ltd.	LJC	Class I	1990-01-29
K895215	Pasco Mic/id Gram-Positive Panel	Difco Laboratories, Inc.	JWY	Class II	1990-01-29
K894370	Genesis III, (Mod. 7003/7004)	Biosound, Inc.	DXK	Class II	1990-01-29
K894322	8400St Volume Ventilator	Bird Products Corp.	CBK	Class II	1990-01-29
K900169	Modified Heartstart 2000 Defibrillation Electrode	Laerdal Mfg. Corp.	LDD	Class II	1990-01-26
K900164	Airway Delivery & Management (Adam) Nasal Ventila.	Medtronic, Inc.	BYE	Class II	1990-01-26
K896957	Powder-Free Vinyl Patient Examination Gloves	Honyee Enterprise Co.	LYY	Class I	1990-01-26