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 2026-10-19, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,018 of the 176,415 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	2,618

176,415 records, page 3026 of 3529

510(k) clearances, page 3026 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K844550	Hobbs Medical/jayco Aspiration Catheter	Hobbs Medical, Inc.	OCX	Class II	1985-01-03
K844458	Nd:yag Laser Pulmonary Obstruction	Endo Lase, Inc.			1985-01-03
K844358	System 920 Photocoagulator to Include Schirmerscop	Coherent Medical Group	HQF	Class II	1985-01-03
K844344	Gemcal Eni Reference Serum	Biocell Laboratories, Inc.	JIX	Class II	1985-01-03
K844332	Creatinine Reagent for Demand Analyzer	Advanced Biomedical Methods, Inc.	CGX	Class II	1985-01-03
K844331	Total Protein Reagent for Demand Analyzer	Advanced Biomedical Methods, Inc.	CEK	Class II	1985-01-03
K844330	Albumin Reagent for Demand Analyzer	Advanced Biomedical Methods, Inc.	CIX	Class II	1985-01-03
K844316	Raichem Phosphorus Reagent	Reagents Applications, Inc.	CEO	Class I	1985-01-03
K844243	Total Bilirubin for Demand Analyzer	Advanced Biomedical Methods, Inc.	CIC	Class II	1985-01-03
K844242	Cholesterol Reagent for Demand Analyzer	Advanced Biomedical Methods, Inc.	CHH	Class I	1985-01-03
K844241	Calcium Reagent for Demand Analyzer	Advanced Biomedical Methods, Inc.	CIC	Class II	1985-01-03
K844185	Modified C-Dak	Cd Medical, Inc.	KOC	Class II	1985-01-03
K844074	Hobbs Medical Polypectomy Snare	Hobbs Medical, Inc.	OCZ	Class II	1985-01-03
K843972	Angioplus-S	Oec-Diasonics, Inc.	JAA	Class II	1985-01-03
K843917	Fluoroscopic Automatic Brightness Cntl	Afp Imaging Corp.	JAA	Class II	1985-01-03
K843839	Stat/pb Reagent	Tri-Tech, Inc.	DOF	Class II	1985-01-03
K843779	Autoloader II	Electro-Nucleonics Laboratories, Inc.	JQW	Class I	1985-01-03
K843748	Anti-Aspiration Valve	Travenol Laboratories, S.A.	FPA	Class II	1985-01-03
K843702	Apparatus & Methods Self-Exam of Eye	Wheel Checkers	HOQ	Class I	1985-01-03
K843646	Steinway Micro-Kerato-Trephine	Steinway Instrument Co., Inc.	HRH	Class I	1985-01-03
K843442	Urinary Drainage Container 2013 with	Vital Metrics, Inc.	FFG	Class II	1985-01-03
K843441	Urinary Drainage Container 2012-with	Vital Metrics, Inc.	FFG	Class II	1985-01-03
K843084	Olympus Chp-P10 Nephroscope/cystoscope	Olympus Corp.	FBO	Class II	1985-01-03
K843040	Copal Digital Thermometer Uf-10	Takeda Medical, Inc.	FLL	Class II	1985-01-03
K844805	Elecath Gallagher Mapping Catheter	Electro-Catheter Corp.	DRF	Class II	1985-01-02
K844789	Kangaroo Access II Enteral Feeding Container	Chesebrough-Pond'S U.S.A. Co.	KNT	Class II	1985-01-02
K844752	Transvenous Balloon Tipped(flow Directed) Temp. Pa	Mansfield Scientific, Inc.	DTB	Class III	1985-01-02
K844691	Endoscopic Aspiration Catheter Set	Jayco Pharmaceuticals	OCX	Class II	1985-01-02
K844690	Endoscopic Multiple Biopsy Instrument	Jayco Pharmaceuticals	FCL	Class I	1985-01-02
K844689	Endoscopic Manual Air Insufflator	Jayco Pharmaceuticals	FCX	Class II	1985-01-02
K844503	Urostresstik Diagnostic Cystometry Pack	Epcom Medical Systems, Inc.	FAP	Class II	1985-01-02
K844365	Color Vision Testers	Luneau Laboratories	HIT	Class I	1985-01-02
K844364	Skiascopic Racks	Luneau Laboratories	HMH	Class I	1985-01-02
K844345	Contour Electrode	Heuristic Medical Systems, Inc.	DRX	Class II	1985-01-02
K844335	Electrocardiograph Electrode	Meditect	DRX	Class II	1985-01-02
K844203	Enternal Feeding Tube Silicone-Ef401, 402 & 403	Exco, Inc.	KNT	Class II	1985-01-02
K844175	Enternal Feeding Tube-Polyurethane Ef504	Exco, Inc.	KNT	Class II	1985-01-02
K844161	Ptca Guiding Cather	Cordis US Corp.	DQO	Class II	1985-01-02
K843128	Female Urinary Incontinence Sys	Chesebrough-Pond'S U.S.A. Co.	KNX	Class II	1985-01-02
K841926	Hydroglide Spring Guide Wires	Argon Medical Corp.	DQX	Class II	1985-01-02
K828543	Unknown	General Electric Co.			1985-01-01
K800023	Lung Aerosol Unit	Cadema Medical Products, Inc.	CAF	Class II	1985-01-01
K833644	Filter Purge Line Ec-Fpl Series	Gish Biomedical, Inc.	DTL	Class II	1984-12-29
K844912	Servo Ventilator 900D Siemens-Elema Ab	Siemens Elema AB	CBK	Class II	1984-12-28
K842964	Photic Stimulator Tm-3030-70	Tracor Northern, Inc.	GWE	Class II	1984-12-28
K844852	The Generic Oxygen Concentrator	Proto-Med, Inc.	CAW	Class II	1984-12-27
K844666	Site Ultrasonic Emulsification Module Op	Chiron Vision Corp.	HQC	Class II	1984-12-27
K844457	Securipin	Hughes Int'L, Inc.	EBL	Class I	1984-12-27
K844350	Newport Ventilator Model E-100	Newport Medical Instruments, Inc.	CBK	Class II	1984-12-27
K844256	Nellcor Pulse Oximeter N-10	Nellcor, Inc.	DQA	Class II	1984-12-27