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 2026-11-05, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,132 of the 176,529 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	2,732

176,529 records, page 2084 of 3531

510(k) clearances, page 2084 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K945589	Consensus(tm) Knee Cobalt Chrome Nonporous Stemmed Tibial Baseplate	U.S. Medical Products, Inc.	JWH	Class II	1995-05-31
K945435	Bryan Posterior Spinal Fixator (Bpsf)	Arcan Orthopaedic Corp.	KWP	Class II	1995-05-31
K932388	Hrt Series 100 Electrophysiology Catheter	Heart Rhythm Technologies, Inc.	DRF	Class II	1995-05-31
K923310	Osteogen (Ha Resorb)	Impladent, Ltd.	LYC	Class II	1995-05-31
K952188	Adviewer 2000	Adp, Ltd.	IXC	Class I	1995-05-30
K951968	Human C1q Radial Immunodiffusion Kit	Kent Laboratories, Inc.	DAK	Class II	1995-05-30
K951967	Human C1 Inactivator or C-1 Esterase Inhibitor Radial Immunodiffusion Kit	Kent Laboratories, Inc.	DBA	Class II	1995-05-30
K951896	Intelivenience Programmable Full Dynamic Range Compression Behind the Ear Hearing Instrument	Siemens Hearing Instruments, Inc.	ESD	Class I	1995-05-30
K951745	Connecting Tube	Vital Signs, Inc.	BSY	Class I	1995-05-30
K951198	Fe-34Th, Fiber Esophagoscope	Pentax Precision Instrument Corp.	GCL	Class II	1995-05-30
K951197	Fe-24X, Fiber Esophagoscope	Pentax Precision Instrument Corp.	GCL	Class II	1995-05-30
K951191	Fcn-15X, Fiber Choledochonephroscope	Pentax Precision Instrument Corp.	FBN	Class II	1995-05-30
K951179	Digital Retinoscopic Photometer	Kudi Kalu, Inc.	HKO	Class I	1995-05-30
K951141	Star Technolgies, Inc. Image Management Server	Star Technologies, Inc.	LMB	Class I	1995-05-30
K950929	Sensi-Touch Epidural Anesthesia Tray	Sherwood Medical Co.	CAZ	Class II	1995-05-30
K950866	Hip Fixation System	Medtec LLC	IYE	Class II	1995-05-30
K950855	Ase Maxi-Torque, Supple Flex Angiographic Catheters	Adam Spence Corp.	DQO	Class II	1995-05-30
K950756	Pulmonex Dynamic Air Therapy Unit	Hill-Rom Inc.	IKZ	Class II	1995-05-30
K950651	Total Shoulder Prosthesis	Encore Orthopedics, Inc.	KWS	Class II	1995-05-30
K950560	Saline Solutine, Sterile	Busse Hospital Disposables	IGE	Class I	1995-05-30
K950390	Urethral Catheterization Tray	Medcare Custom Packaging, Inc.	FCM	Class II	1995-05-30
K946382	Skalpi 3200	Wiscco Development, Inc.	IRO	Class I	1995-05-30
K945841	Birth Theft Infant Identification and Protection Umbilical Cord Clamp	W G M Corp.	HFW	Class II	1995-05-30
K945783	Orthomet Titanium Hybrid Femoral Stem	Orthomet, Inc.	JDG	Class II	1995-05-30
K945625	Altra Nova(tm) 140 Hemodialyzer	Althin Medical AB an Affiliate of Baxter Intl	KDI	Class II	1995-05-30
K945621	Altra Nova(tm) 170 Hemodialyzer	Althin Medical AB an Affiliate of Baxter Intl	KDI	Class II	1995-05-30
K945574	Osteonics(r) Ccr Hip Stem Series	Osteonics Corp.	JDI	Class II	1995-05-30
K945270	Custom Artificial Human Eyes	Daniel T Acosta	HQH	Class I	1995-05-30
K944756	Isola Open and Closed Screws	Acromed Corp.	MNH	Class II	1995-05-30
K943950	Ethicon Nonabsorbable Suture Anchor	Ethicon, Inc	JDR	Class II	1995-05-30
K943908	Infinity Shoulder System	Wrightmedicaltechnologyinc	HSD	Class II	1995-05-30
K942626	Continuous Flow Biopsy Probe	Gm Engineering, Inc.	FDC	Class II	1995-05-30
K942558	Instacine	Fidelity Medical, Inc.	LMB	Class I	1995-05-30
K941153	Epi-Spinal Anesthesia Tray	Preferred Medical Products, LLC	CAZ	Class II	1995-05-30
K952300	Midas Rex Motors (Midas I, II & Convertible Models)	Midas Rex Pneumatic Tools, Inc.	GET	Class I	1995-05-26
K951933	Urotek Re-Usable Fiberoptic Cable	Energy Life Systems Corp.	GEX	Class II	1995-05-26
K951324	Maxol Image II Patient Matched Breast Prosthesis	Maxol Limited L.C.	KCZ	Class I	1995-05-26
K950880	Aoi Universal Ultrasonic Handpiece	American Optical Corp.	HQC	Class II	1995-05-26
K950861	Reconstitution Accessoreis	Organon LLC	FPK	Class II	1995-05-26
K950831	Alexlazr	Candela Corporation	GEX	Class II	1995-05-26
K950311	Global Medical Products Brest Lesion Localization Needle with Stiffened Wire	Global Medical Products, Ltd.	GDF	Class I	1995-05-26
K945262	Optus Cystoscopes and Pediatric Cystoscopes	Optus, Inc.	FAJ	Class II	1995-05-26
K944699	Att-300	Health Care Mfg., Inc.	ITH	Class II	1995-05-26
K944083	Monoject(r) Samplette(r) Collection Tube	Sherwood Medical Co.	JKA	Class II	1995-05-26
K943935	Gip/medi-Globe Polypectomy Snares	Medi-Globe GmbH	FDI	Class II	1995-05-26
K943629	Gip/medi-Globe Papillotome	Medi-Globe GmbH	KNS	Class II	1995-05-26
K941282	ECG Fax Modem	Hewlett-Packard Co.	LOS		1995-05-26
K940324	Spectacle Sun Glasses	Occhiali, International Eyewear	HQY	Class I	1995-05-26
K952204	Conmed/aspen Labs Coated Laparoscopic Electrosurgical Blades	Conmedcorp	GEI	Class II	1995-05-25
K952098	Siemens Pc Auidiometer Model Sd 100 & Pc Probe Mic System Model Sd 110/Sd with Unity Sopftware Suite	Siemens Hearing Instruments, Inc.	ETW	Class II	1995-05-25