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 3285 of 3528

510(k) clearances, page 3285 of 3528
K number	Device	Applicant	Product code	Class	Decision date
K811677	Krypton Cart	Medi-Physics Inc. dba Nycomed Amersham Imaging	KPY	Class I	1981-07-02
K811676	Maxi Camera/d	General Electric Co.	IYX	Class I	1981-07-02
K811654	Brain Heart Infusion Agar	Neogen Culture Media	JSG	Class I	1981-07-02
K811653	Phytone	Neogen Culture Media	JSK	Class I	1981-07-02
K811652	Polypeptone Peptone	Neogen Culture Media	JSK	Class I	1981-07-02
K811651	Trypticase	Neogen Culture Media	JSG	Class I	1981-07-02
K811650	Macconkey Broth	Neogen Culture Media	JSJ	Class I	1981-07-02
K811649	Gelysate	Neogen Culture Media	JSK	Class I	1981-07-02
K811648	Endo Agar	Neogen Culture Media	JSI	Class I	1981-07-02
K811647	Salmonella-Shigella Agar	Hardy Media	JSI	Class I	1981-07-02
K811646	Mueller Hinton Agar	Hardy Media	JTZ	Class II	1981-07-02
K811645	Thayer-Martin, Gc Agar Base	Hardy Media	JTY	Class II	1981-07-02
K811644	Hektoen Enteric Agar	Hardy Media	JSI	Class I	1981-07-02
K811643	Macconkey Agar	Hardy Media	JSI	Class I	1981-07-02
K811642	Eosin Methylene Blue Agar (Levine)	Hardy Media	JSI	Class I	1981-07-02
K811641	Columbia Agar Base	Hardy Media	JSG	Class I	1981-07-02
K811640	Medicase Soy Agar	Hardy Media	JSG	Class I	1981-07-02
K811623	Smr Paragon Chair Table	Smr	LGX	Class I	1981-07-02
K811554	Barnes-Hind Spectacle Lens Cleaner	Barnes-Hind, Inc.	HQG	Class I	1981-07-02
K811520	Grayline Imaging System	Sonics Research Corp.	HEM	Class II	1981-07-02
K811450	Aluminum Filtration System	Wedge Filtration System	KPW	Class II	1981-07-02
K811397	Eca	Gillco, Inc.	FOA	Class I	1981-07-02
K811316	Triscan, Models 38,40,41,43 & 45	Visidyne Corp.	IYO	Class II	1981-07-02
K811216	Resident Bedside Monitor	Abbott Medical	DRT	Class II	1981-07-02
K811078	Radiation Sterilized Admin. Set	Travenol Laboratories, S.A.	FPA	Class II	1981-07-02
K810928	Endocardial Electrode	Vitatron Medical BV	DTB	Class III	1981-07-02
K811711	Pediatric Oxygen Masks	Airlife, Inc.	BYG	Class I	1981-07-01
K811708	Universal Adapter System-U/adapit	Airlife, Inc.	BZA	Class I	1981-07-01
K811704	Multitubular Air Splint Kit	Roger Cestac & Assoc.	IQI	Class I	1981-07-01
K811701	Chloride/carbon Dioxide Rate Reagent	Chem-Elec, Inc.	JFS	Class II	1981-07-01
K811696	Il #781, Semi-Automated Loader	Instrumentation Laboratory Co.	JQW	Class I	1981-07-01
K811695	Helena Fetal-Tek 200 Marker	Helena Laboratories, Corp.	JJY	Class I	1981-07-01
K811694	Centrifichem Alt/agpt Optimized Reagent	Baker Instructions Corp.	CKA	Class I	1981-07-01
K811687	Uric Acid Test	King Diagnostics, Inc.	KNK	Class I	1981-07-01
K811669	Durafill Microfill Restorative Material	Kulzer GmbH	EBF	Class II	1981-07-01
K811657	P.d. Cradle	Lung Care, Inc.			1981-07-01
K811655	Myelostat Dorsal Cord Stimulator	Medtronic, Inc.	GZB	Class II	1981-07-01
K811630	Kinematic Rotating Hinge Total Knee Pr.	Howmedica Corp.	LGE	Class II	1981-07-01
K811626	Meddars/ultra Imager Pulse/phon Module	Honeywell, Inc.	DQC	Class I	1981-07-01
K811592	Liquizyme Single Solution Glucose Reag	Amresco, Inc.	CGA	Class II	1981-07-01
K811578	Dahlberg Model Ap Hearing Aid	Dahlberg Electronics, Inc.	ESD	Class I	1981-07-01
K811555	Dental Floss Holder	Sewon Industry	JES	Class I	1981-07-01
K811539	Cordis Encor Pewenous Ventricular Bipol	Cordis US Corp.	DTB	Class III	1981-07-01
K811524	Aquacade	Respiratory Care, Inc.	LHC	Class I	1981-07-01
K811449	Haemonetics 1000Ml Component Bag	Haemonetics Corporation	KSR	Class II	1981-07-01
K811350	Unipolar Spectrax Impl. Pulse Generat.	Medtronic, Inc.	DXY	Class III	1981-07-01
K811218	Acmi Aspirator Kit #8808	American Cystocope Makers, Inc.	EOQ	Class II	1981-07-01
K811183	Denver Peritoneo-Venous Shunt	Denver Biomedicals, Inc.	KPM	Class II	1981-07-01
K811115	Superflow Cannula for Arthros. Surgery	The Anspach Effort, Inc.			1981-07-01
K811108	Rmi Transillumination Light Meter #295	Radiation Measurements, Inc.	HJM	Class II	1981-07-01