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 2565 of 3530

510(k) clearances, page 2565 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K900300	Lytening 2Z Lytening System 31	Baxter Healthcare Corporation	CEM	Class II	1990-03-01
K900266	Sterile Carbon Steel Surgical Blade	Rahn Laboratories	GES	Class I	1990-03-01
K900250	Amresco Alkaline Phosphatase Reagents 7780 & 7781	American Research Products Co.	CJE	Class II	1990-03-01
K900224	Stat Fax(tm)-2100	Awareness Technology, Inc.	JJQ	Class I	1990-03-01
K900147	Modified Dsl-2300 Acth Ria	Diagnostic Systems Laboratories, Inc.	CKG	Class II	1990-03-01
K897161	Coulter Uric Acid Reagent	Coulter Electronics, Inc.	KNK	Class I	1990-03-01
K897158	Abbott Commander Parallel Processing Center	Abbott Medical	JQW	Class I	1990-03-01
K897128	Umi Braided Catheter Connector	Universal Medical Instrument Corp.	LYY	Class I	1990-03-01
K896991	Enzymun Test(r) Tbk	Boehringer Mannheim Corp.	CEE	Class II	1990-03-01
K896924	Spiroscan 4000	Brentwood Instruments, Inc.	BZG	Class II	1990-03-01
K896794	Specimen Container	Westmark, Sterile Packing Systems, Inc. (Sps)	LIO	Class I	1990-03-01
K896583	F.a.s.t. Table	Oec-Diasonics, Inc.	IXR	Class II	1990-03-01
K896465	Clp Ck/ld Isoenzyme/immuno Control	Creative Laboratory Products, Inc.	JJT	Class I	1990-03-01
K900427	IV Trifurcated Extension Set	Marquette Medical, Inc.	FPA	Class II	1990-02-28
K900426	IV Bifurcated Extension Set	Marquette Medical, Inc.	FPA	Class II	1990-02-28
K900387	Disco Sunglasses (Non-Prescription)	Le-I Electronic Co., Ltd.	HQY	Class I	1990-02-28
K900282	Needle-Shield	Macbrud Corp. Medical Div.	FMI	Class II	1990-02-28
K897085	Comfees(r) + Con-Pak(tm) Lens Case	FGX International Inc.	LRX	Class II	1990-02-28
K897084	Confees(r)+ Contact Lens Holder	FGX International Inc.	LRX	Class II	1990-02-28
K896978	Closed Chest Support Circuit W/bio-Active Surface	Medtronic, Inc.	DTZ	Class II	1990-02-28
K896849	Acs Indeflator Xx	Advanced Cardiovascular Systems, Inc.	MAV	Class II	1990-02-28
K896741	Schneider Monorail-Pmc Pressure Monitoring Cath.	Schneider Intl., Ltd.	DQO	Class II	1990-02-28
K896737	Type 9292 Interface Capnograph	S & W Medico Teknik	CCK	Class II	1990-02-28
K896736	Type 9291 Interface Respirator	S & W Medico Teknik	CBK	Class II	1990-02-28
K896735	Type 9290 Interface Respirator	S & W Medico Teknik	CBK	Class II	1990-02-28
K896039	King of Hearts 1200 Monitor	Instromedix, Inc.	DXH	Class II	1990-02-28
K895776	Aiv Systems' IV Poles	Automated IV Systems, Inc.	FOX	Class I	1990-02-28
K895511	Catheter Balloon Dilator Pressure Gauge	Argon Medical Corp.	MAV	Class II	1990-02-28
K895179	Accessor Peripheral Dilating Guide Wire	Peripheral Systems Group	LIT	Class II	1990-02-28
K894826	Univox W/holders, Models Univox-Hl, Hlb, Hlf	Bentley Laboratories, Inc.	DTZ	Class II	1990-02-28
K893711	Dideco-Shiley Autotransfusion Cardiotomy Reservoir	Shiley, Inc.	DTN	Class II	1990-02-28
K893221	Model 8500 Hand Held Pulse Oximeter	Nonin Medical, Inc	DQA	Class II	1990-02-28
K890182	Protegraft Dv 1500, 1900 & Low Por, Unigraft Dv	Aesculap Instruments Corp.	DSY	Class II	1990-02-28
K885046	Insitucat Valve Stripper	Aesculap Instruments Corp.	DWQ	Class II	1990-02-28
K900579	Autoreader Calibration Test Plate	Bio-Tek Instruments, Inc.	JJQ	Class I	1990-02-27
K900525	Model F 1 Flip-Up Sunglasses W/polycarbonate Blue	J & B Assoc.	HQY	Class I	1990-02-27
K900523	Model F3 Flip-Up Sunglasses W/acrylic Orange Comp.	J & B Assoc.	HQY	Class I	1990-02-27
K900514	Jyrochair Power Wheelchair	Jyrochair, Inc.	ITI	Class II	1990-02-27
K900422	Titan Gel Immunofix Kit, Cat. No. 3046	Helena Laboratories, Corp.	CZP	Class II	1990-02-27
K900419	Cryotron-Ul30	Henley Intl.	IMF	Class I	1990-02-27
K900384	Infravib Massager - Model Pr-1000	Infralux International, Inc.	ILY	Class II	1990-02-27
K900259	Direct Bilirubin Reagent	Medical Analysis Systems, Inc.	CIG	Class II	1990-02-27
K900129	Modified Auto Suture Endoscopic Gia Surg. Stapler*	United States Surgical, A Division of Tyco Healthc	GDW	Class II	1990-02-27
K900006	Catheter Adapter Sealing Cap No. 48-1028-9	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-02-27
K900004	Convertible Adapter Catalog No. 48-4039-3	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-02-27
K897110	Satellite K+ Blood Potassium Monitoring System	Medisense, Inc.	CEM	Class II	1990-02-27
K896956	Quick Disconnect Clamp Catalog No. 48-0300-3	National Medical Care, Medical Products Div., Inc.	KDJ	Class II	1990-02-27
K896778	Rmi Vasoplegia Cannula with & without Check Valve	Research Medical, Inc.	DWF	Class II	1990-02-27
K896777	Rmi Aortic Root Pressure Monitor Extension Line	Research Medical, Inc.	DWF	Class II	1990-02-27
K896676	Key Vascular Loops	Key Surgical, LLC	KDC	Class I	1990-02-27