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 2026-10-12, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

45,969 of the 176,366 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	2,569

176,366 records, page 3258 of 3528

510(k) clearances, page 3258 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K813247	Kaneson/comfort Plus Manual Breast Pump	Marshall Electronics, Inc.	HGY	Class I	1981-12-03
K813241	Emit-Aad Theophylline Control	Syva Co.	LAS	Class I	1981-12-03
K813240	Emit-Aad Theophylline Assay	Syva Co.	LER	Class II	1981-12-03
K813236	Epican Epidural Cannula, Bevel Accord	Burron Medical Products, Inc.	BSP	Class II	1981-12-03
K813232	Cooked Meat Medium	Oxoid U.S.A., Inc.	JSG	Class I	1981-12-03
K813225	Gel Flotation Cushion	Jefferson Industries, Inc.	KIC	Class I	1981-12-03
K813203	C-Terminal Pth Ria Test Kit, Dsl-1000	Diagnostic Systems Laboratories, Inc.	CEW	Class II	1981-12-03
K813191	Shigella Sera-Chek	Lab Ability, Inc.	LIA	Class II	1981-12-03
K813186	Perfix Set for Epidural Anesthesia W/tuo	Burron Medical Products, Inc.	CAZ	Class II	1981-12-03
K813179	Perican, Epidural Cannula	Burron Medical Products, Inc.	BSP	Class II	1981-12-03
K813171	Phenylalanine UV Kinetic Test Kit	Biochemicals, Inc.	JNB	Class II	1981-12-03
K813169	Celestin Pulsion Esophogeal Prosthesis	Inmed Corp.	KNT	Class II	1981-12-03
K813168	Liquizyme Glucose Reagent	American Research Products Co.	CGA	Class II	1981-12-03
K813165	Plexufix Brachial Plexus Anesth. Needle	Burron Medical Products, Inc.	BSP	Class II	1981-12-03
K813128	Mobil-Aid Automatic Exposure Control	Advanced Instrument Development, Inc.	IZL	Class II	1981-12-03
K813058	Portable Oxygen Generator	Respiratory Marketing, Inc.	CAW	Class II	1981-12-03
K813024	Wa1000	CooperSurgical, Inc.	GEH	Class II	1981-12-03
K812997	Filter Flow Mask Cat. #350	Eldredge Mfg. Co.	FXX	Class II	1981-12-03
K812996	Filter Flow Mask Cat. #300	Eldredge Mfg. Co.	FXX	Class II	1981-12-03
K812992	Surgical Mask	South Mountain Medical	FXX	Class II	1981-12-03
K812850	Ptt-200 Pulmonary Receiver/microproces	Pharmaquest Corp.	BTY	Class II	1981-12-03
K812849	Ptt-200 Telephonic Pulmonary Transmitt	Pharmaquest Corp.	BTY	Class II	1981-12-03
K812840	Serum Iron Reagent Set	Anco Medical Reagents & Assoc.	JIY	Class I	1981-12-03
K812839	Hdl Cholesterol Reagent Set	Anco Medical Reagents & Assoc.	LBR	Class I	1981-12-03
K812838	Triglyceride Reagent Set	Anco Medical Reagents & Assoc.	CDT	Class I	1981-12-03
K812834	Creatinine Reagent Set	Anco Medical Reagents & Assoc.	CGX	Class II	1981-12-03
K812811	Microcoil 80 Dialyzer	Erika, Inc.	FHS	Class II	1981-12-03
K812803	Infant Percussor #5534	Hudson Oxygen Therapy Sales Co.	BYI	Class II	1981-12-03
K812744	Levy Biotac #Lx001 Biopsy Probe Holder	Progress Mankind Technology	HAW	Class II	1981-12-03
K813242	Quantimetric 2 Test Kit	Kallestad Laboratories, Inc.	KEW	Class I	1981-12-02
K813226	Gel Flotation Mattress	Jefferson Industries, Inc.	IKY	Class I	1981-12-02
K813194	Auto-Syringe Sub-Cuteaneous Set	Baxter Healthcare Corporation	FPA	Class II	1981-12-02
K813154	Adapting Sleeve	Pacesetter Systems	DTD	Class II	1981-12-02
K813153	Test Magnet	Pacesetter Systems	DTG	Class I	1981-12-02
K813152	Electrode Terminal Cap	Pacesetter Systems	DTD	Class II	1981-12-02
K813151	Vitatron Insert	Pacesetter Systems	DTD	Class II	1981-12-02
K813150	Directional Boot	Pacesetter Systems	DXY	Class III	1981-12-02
K813137	Correc Torr Tm	Norton Performance Plastics Corp.	DRS	Class II	1981-12-02
K813057	Vibro-Com Communicator #8827	Sonic Systems, Inc.	LRA	Unclassified	1981-12-02
K813050	Aquanomics, #Mp4sf	Cooper-Hewitt Electric Co.	KMG	Class II	1981-12-02
K813049	Aquanomics, #Hhu100	Cooper-Hewitt Electric Co.	KMG	Class II	1981-12-02
K813048	Aquanomics, #Mp2sf	Cooper-Hewitt Electric Co.	KMG	Class II	1981-12-02
K813047	Aquanomics, Mini 60L	Cooper-Hewitt Electric Co.	KMG	Class II	1981-12-02
K813046	Aquanomics, #Hhu60	Cooper-Hewitt Electric Co.	KMG	Class II	1981-12-02
K813045	Aquanomics, #Sp36sf	Cooper-Hewitt Electric Co.	KMG	Class II	1981-12-02
K813023	Fukuda Denshi Cardimax Fk-11	Brentwood Instruments, Inc.	DSP	Class II	1981-12-02
K813022	Fukuda Denshi Cardimax Fk-12	Brentwood Instruments, Inc.	DPS	Class II	1981-12-02
K813015	Helioseal	Vivadent (USA), Inc.	EBC	Class II	1981-12-02
K813008	Respond Ii...neuromuscular Stimulator	Medtronic, Inc.	IPF	Class II	1981-12-02
K812949	Rmi Transilluminator, Model 292	Radiation Measurements, Inc.	HJM	Class II	1981-12-02