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 2026-10-22, 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 2973 of 3529

510(k) clearances, page 2973 of 3529
K number	Device	Applicant	Product code	Class	Decision date
K852886	Mug Disk	Remel Inc	JTO	Class I	1985-07-23
K852871	Ids Rapid Ss/u System	Innovative Diagnostic Systems, Inc.	JSS	Class I	1985-07-23
K852870	Barrier Surgical Gown	Surgikos, Inc.	FYA	Class II	1985-07-23
K852863	Cholesterol Method	Catachem, Inc.	CHH	Class I	1985-07-23
K852787	Technicon H*1 System	Technicon Instruments Corp.			1985-07-23
K852752	Amresco Flow Pac Alkaline Phosphatase Buffer Conce	American Research Products Co.	CJE	Class II	1985-07-23
K852640	Monoject Sterile 35Cc Syringes	Sherwood Medical Co.	FMF	Class II	1985-07-23
K852607	Monject Sterile 20Cc Syringes	Sherwood Medical Co.	FMF	Class II	1985-07-23
K852588	Monoject Sterile 6Cc Syringe W/ & Wo/ Needles	Sherwood Medical Co.	FMF	Class II	1985-07-23
K852580	Monoject Sterile 60Cc Syringes	Sherwood Medical Co.	FMF	Class II	1985-07-23
K852544	Monoject Sterile 3Cc Syringes W/ & Wo/ Needles	Sherwood Medical Co.	FMF	Class II	1985-07-23
K852539	Suszoi Ultrasonic Surgical Aspirator Sonop	Johnson & Johnson Professionals, Inc.	LFL	Unclassified	1985-07-23
K852211	Opsite Wound Dressing	Smith & Nephew, Inc.	NAD	Class I	1985-07-23
K851669	Monitor IV Plus	Helena Laboratories, Corp.	JOZ	Class II	1985-07-23
K851663	Quick-Count Hematology Controls	Seragen Diagnostics, Inc.	JPK	Class II	1985-07-23
K851651	Hgm Endocoagulator Model 8	Hgm, Inc.			1985-07-23
K851641	Thrombosil Silica Activated Ptt Reagent Thromboxil	Ortho Diagnostic Systems, Inc.	MSJ	Class I	1985-07-23
K851203	R Pak	CooperVision, Inc.	LFL	Unclassified	1985-07-23
K852844	Amresco Flow Pac Total Protein Biuret & Blank Conc	American Research Products Co.	CEK	Class II	1985-07-22
K852784	Alkaline Phosphatase	Advanced Biomedical Methods, Inc.	CJE	Class II	1985-07-22
K852783	Sgot/alt Reagent	Advanced Biomedical Methods, Inc.	CIT	Class II	1985-07-22
K852676	Il System 1304 & 1306, Ph/blood Gas Analyzers	Allied Instrumentation Laboratory	CHL	Class II	1985-07-22
K852675	Amerlex-M B-Human Chorionic Gonadtropin Radioi Kit	Amersham Corp.	JHI	Class II	1985-07-22
K852671	Aca Tobramy-Cin Analytical Test Pack	E.I. Dupont de Nemours & Co., Inc.	KLB	Class II	1985-07-22
K852556	Tdx Rea Triglycerides	Abbott Medical	JGW	Class I	1985-07-22
K852295	Urol-Guant	Dimension Diagnostics	JJW	Class I	1985-07-22
K852260	Quick-Chem Calibration Set	Seragen Diagnostics, Inc.	JIW	Class II	1985-07-22
K852164	Cedia Total T4 Assay	Microgenics Corporation	KLI	Class II	1985-07-22
K851610	Combined Mvs Systems	Medical Instrument Development Laboratories, Inc.	HQE	Class II	1985-07-22
K851082	V. Mueller Blom-Singer Esophageal Insufflation Tes	American V. Mueller	ENW	Class I	1985-07-22
K850180	Electronystagmograph (Eng Recorder)	Bio-Logic Systems Corp.	GWN	Class II	1985-07-22
K843227	Macular Function Analyzer	Danek Medical, Inc.	HOQ	Class I	1985-07-22
K852832	Identicult-Neisseria	Scott Laboratories, Inc.	JTO	Class I	1985-07-19
K852789	Aeromonas Agar(xdca)	Gibco Laboratories Life Technologies, Inc.	JSI	Class I	1985-07-19
K852701	Fisher Diagnostic Latest Aso Test Kit	Allied Fisher Scientific	GTQ	Class I	1985-07-19
K852677	Mts4400 Metabolic & Respiratory Testing System	Alpha Technologies, Inc.	BZG	Class II	1985-07-19
K852634	Micro-Focus 50 Cabinet X-Ray	Micro-Focus Imaging., Inc.	MWP	Class II	1985-07-19
K852431	Suprima II Model 254-26	Intermedics, Inc.	DXY	Class III	1985-07-19
K852390	Cmt 1000	Prestigeline, Inc.	KQX	Class I	1985-07-19
K852264	Ebi Foot Massaging Pump	Electro-Biology, Inc.	IRP	Class II	1985-07-19
K852157	Temrex Dental Polishing Paste	Scientific Pharmaceuticals, Inc.	EJR	Class I	1985-07-19
K852065	Preston Lower Limb Cpm Unit	Therapeutic Equipment Corp.	BXB	Class I	1985-07-19
K852044	Culturette Brand Rapid Latex Test Clostridium Toxi	Marion Laboratories, Inc.	LLH	Class I	1985-07-19
K852015	Jyrochair, Model Sk-H	Medco Products, Co., Inc.	ITI	Class II	1985-07-19
K851967	Torque Feedback Meter	Th Charters, Inc.	ISD	Class II	1985-07-19
K851946	Remote Speed Control	Th Charters, Inc.	ISD	Class II	1985-07-19
K851900	Sea Med Ddd Pacing System Analyzer	Seamed Corp.	DTC	Class II	1985-07-19
K851891	Terran One Biomechanical Analysis Systems	Richard Scott Elliott	LOJ	Class II	1985-07-19
K851848	Percutaneous Transluminal Blood Dilation Catheter	Mansfield Scientific, Inc.	LIT	Class II	1985-07-19
K851565	Homedica Cemented Acetabular Component 6262	Howmedica Corp.	DXQ	Class II	1985-07-19