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 2055 of 3531

510(k) clearances, page 2055 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K950415	Fluoroscan Neonatal	Isolab, Inc.	KHO	Class I	1995-09-05
K953933	Med-Tech Laser Gas Mixture	Medical Technical Gases Inc.	GEX	Class II	1995-09-01
K953827	Gip/medi-Globe Ercp Catheters	Medi-Globe GmbH	FGE	Class II	1995-09-01
K953781	Innovative Technologies Calcium Alginate Wound Dressings	Innovative Technologies, Ltd.	KMF	Class I	1995-09-01
K953484	Pollux Oa/pollux 30A/pollux 70A	Pollux Endoscopy, Inc.	HRX	Class II	1995-09-01
K953366	Quanta Lite Iga Aca (Hrp)	Inova Diagnostics, Inc.	MID	Class II	1995-09-01
K953075	Unimat Pump	Karl Storz Endoscopy-America, Inc.	HRX	Class II	1995-09-01
K952586	Gamp & Associates Disposable Fiberoptic Endoilluminator	Gamp & Assoc.	MPA	Class II	1995-09-01
K952584	Gamp & Associates Disposable Endoilluminator W/pick	Gamp & Assoc.	MPA	Class II	1995-09-01
K952580	Gamp & Associates Disposable Bare End Fiber	Gamp & Assoc.	MPA	Class II	1995-09-01
K952364	Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)	Ela Medical, Inc.	DXY	Class III	1995-09-01
K952245	Sf-Check	Streck Laboratories, Inc.	JPK	Class II	1995-09-01
K952043	Back Massager	Eight Corners, Inc.	LYG	Class I	1995-09-01
K951996	Imagyn Endoscope	Imagyn Medical, Inc.	GCJ	Class II	1995-09-01
K951939	Tender Temp	Investech, Ltd.	FLL	Class II	1995-09-01
K951932	Osteonics Restoration Monolithic II Hip Stem Series	Osteonics Corp.	MEH	Class II	1995-09-01
K951908	Regent Biogel Latex-Free Surgeon's Glove	Regent Hospital Products	KGO	Class I	1995-09-01
K951561	Dynasorb	Dermarx Corp.	KMF	Class I	1995-09-01
K951497	Cascase 480 Snslyzer	Helena Laboratories, Corp.	JPA	Class II	1995-09-01
K951267	Stryker Universal Acl Instrumentation System	Stryker Corp.	HRX	Class II	1995-09-01
K950895	Harmac Extension Infusion Set	Harmac Medical Products	FPA	Class II	1995-09-01
K950865	Rogozinski Spinal Rod System Rod-to-Bolt (Universal) Connector for Use with the Simmons Plating System Bolt	Smith & Nephew Richards, Inc.	MNH	Class II	1995-09-01
K946033	Leibinger Stereoplan Plus Sterotactic Treatment Plan Ing Software Package	Leibinger GmbH	HAW	Class II	1995-09-01
K944593	Stryker Pressure Sensing Cannula	Stryker Corp.	HRX	Class II	1995-09-01
K942769	Biointegrator, Biointegrator Plus	Bio Research Institute	HCC	Class II	1995-09-01
K941577	Dynatron 550	Dynatronics Corp.	LIH	Class II	1995-09-01
K941461	Dynatron 850	Dynatronics Research Corp.	LIH	Class II	1995-09-01
K932947	Wallace Y-Can	Smiths Industries Medical Systems, Inc.	FOZ	Class II	1995-09-01
K932946	Wallace IV Cannula	Smiths Industries Medical Systems, Inc.	FOZ	Class II	1995-09-01
K930084	Micro-Arthroscope	Medical Devices Inc.	HRX	Class II	1995-09-01
K953395	Synermed Calcium Reagent Kit	Synermed, Inc.	CJY	Class II	1995-08-31
K953069	Amerimed As110	Amerimed Systems L.C.	FNM	Class II	1995-08-31
K952815	Dupont Lipase Calibrator	Dupont Medical Products	JIT	Class II	1995-08-31
K952732	Medical Grade Silicone Block	Bioplexus Corp.	MIB	Class II	1995-08-31
K952566	Oscilflator	Surgical Technologies, Inc.	MAV	Class II	1995-08-31
K952206	Passive Plus Pacing Leads with Titanium Nitride Coating	Pacesetter, Inc.	DTB	Class III	1995-08-31
K951950	Passive Plus Pacing Leads with Titanium Nitride Coating	Pacesetter, Inc.	DTB	Class III	1995-08-31
K943516	Rotachrom Hbpm/lmwh Test Kit	American Bioproducts Co.	KFF	Class II	1995-08-31
K943515	Rotachrom Heparin Test Kit	American Bioproducts Co.	KFF	Class II	1995-08-31
K932571	Tomey Pe-400 Portable Erg & Vep with Optional Ps-4	Tomey Corporation USA	GWE	Class II	1995-08-31
K953547	Manan Nephrostomy Drainage Catheter	Argon Medical Devices, Inc	LJE	Unclassified	1995-08-30
K952812	3I Oral/maxillofacial Bone Fixation System: Cocrmo Alloy (Vitalium) Bone-Mesh/plate & Screws	ZimVie US Corp LLC	JEY	Class II	1995-08-30
K952811	3I Oral/maxillofacial Bone Fixation System: Stainless Steel Bone-Mesh/plate & Screws	ZimVie US Corp LLC	JEY	Class II	1995-08-30
K952459	Medtronic Model 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C Leads or, Transverse Tripolar Leads or, Ttl	Medtronic, Inc.	GZB	Class II	1995-08-30
K950624	Ha- and Tps- Restore Self Tapping Dental Implant System	Lifecore Biomedical LLC	DZE	Class II	1995-08-30
K944724	Health Image Inc. Hi Star	Health Images, Inc.	LNH	Class II	1995-08-30
K941362	Bone Mineral Densitometer	Hologic, Inc.	KGI	Class II	1995-08-30
K935554	Quikpac II Onestep Strep a Immunochromatographic Assay	Syntron Bioresearch, Inc.	GTZ	Class I	1995-08-30
K935475	Quikstrip Onestep Strep a Test Immunochroma Assau	Syntron Bioresearch, Inc.	GTZ	Class I	1995-08-30
K953527	Permualute Indirect Restorative Bonding Primers	Ultradent Products Inc.	KLE	Class II	1995-08-29