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 1974 of 3531

510(k) clearances, page 1974 of 3531
K number	Device	Applicant	Product code	Class	Decision date
K961763	Pulse*spray Infusion System	Angiodynamics, Div. E-Z-Em, Inc.	QEY	Class II	1996-07-17
K960029	Hydrasys Agarose Gel Electrophoresis Apparatus/hydragel 15,30 Protein Kit	Morax	CEF	Class I	1996-07-17
K954982	Ksea Scalp Blood Collection Set	Karl Storz Endoscopy-America, Inc.	HGK	Class II	1996-07-17
K962410	N Protein Standard Py	Behring Diagnostics, Inc.	JIX	Class II	1996-07-16
K962406	N Crp Standard Sy	Behring Diagnostics, Inc.	JIX	Class II	1996-07-16
K961997	Ussc Braided Synthetic Absorbable Suture	United States Surgical, A Division of Tyco Healthc	GAM	Class II	1996-07-16
K961988	Valproic Acid Eia Test	Diagnostic Reagents, Inc.	LEG	Class II	1996-07-16
K961775	Profore Four-Layer Bandage System Kit	Smith & Nephew United, Inc.	EFQ	Unclassified	1996-07-16
K961701	Mouse Anti-Human Cd3, T-Cell, Fitc and Cd4, T-Cell, (Helper/inducer) Rpe	Dako Corp.	GKZ	Class II	1996-07-16
K961650	Nichols Advantage Chemiluminescence Thyroid Stimulating Hormone Third Generation Kit	Nichols Institute Diagnostics	JLW	Class II	1996-07-16
K961649	Acufex Tibial Anchor Screw & Spiked Washer	Smith & Nephew Endoscopy, Inc.	HWC	Class II	1996-07-16
K961476	Salterlabs 8960 Series Nebulizer (8960/8961/8966/8984)	Salter Labs	CAF	Class II	1996-07-16
K961468	Quik-Fil Vaporizer Keyed Filler	Penlon, Ltd.	CAD	Class II	1996-07-16
K960658	Collarless Polished Taper Hip Prosthesis	Zimmer GmbH	JDI	Class II	1996-07-16
K952969	Eidos 5003 Holter System	New Product Development, Inc.	DQK	Class II	1996-07-16
K951541	Imx Rubella Igg	Abbott Medical	LFX	Class II	1996-07-16
K962413	Comfort Cath Special Self Adhering Male External Catheter	Sierra Laboratories, Inc.	EXJ	Class I	1996-07-15
K962384	Comfort Sheath Reusable Male External Catheter	Sierra Laboratories, Inc.	EXJ	Class I	1996-07-15
K962182	Burlew Infant Hood	Promedic, Inc.	FOG	Class I	1996-07-15
K961926	Sanpoint Menstrual Tampon	Sanpoint AB	HEB	Class II	1996-07-15
K961846	Needle Catheter	Boston Scientific Corporation	FBK	Class II	1996-07-15
K961799	Natural Hip System - Drg Hip Stem	Intermedics Orthopedics	JDI	Class II	1996-07-15
K961766	Wound Hydrogel & Sterile Wound Hydrogel	Renaissance Pharmaceutical, Inc.	MGQ	Unclassified	1996-07-15
K961747	Arthrocare Arthroscopic Electrosurgery System (Model 970)	ArthroCare Corporation	HRX	Class II	1996-07-15
K961673	R&d Retic-Pg Hematology Control	R & D Systems, Inc.	JPK	Class II	1996-07-15
K961316	Wound Hydrogel And/or Sterile Wound Hydrogel	Renaissance Pharmaceutical, Inc.	MGQ	Unclassified	1996-07-15
K961118	Maxim Pf Models 033-581/033-590	Telectronics Pacing Systems, Inc.	DTB	Class III	1996-07-15
K961101	Stryker Cement Removal System	Stryker Corp.	LZV	Class II	1996-07-15
K961077	Pep (Positive Expiratory Pressure) Therapy Device	Healthscan Products, Inc.	BWF	Class II	1996-07-15
K961036	Mbi Fiberoptic Endo-Illuminator	M.B. Industries, Inc.	MPA	Class II	1996-07-15
K960725	Marpp Pressure Monitoring System	Paradigm Medical, Inc.	KYZ	Class I	1996-07-15
K955416	Cardimax Model Fx-2111	Fukuda Denshi USA, Inc.	DPS	Class II	1996-07-15
K954900	3M Red Dot ECG Lead Wires a	Minnesota Mining and Mfg. Co.	DSA	Class II	1996-07-15
K952415	Durex, Ramses, Sheik	London International U.S. Holdings, Inc.	LTZ	Class II	1996-07-15
K951902	Pathfinder 700 Holter Analyzer	Reynolds Medical, Ltd.	DQK	Class II	1996-07-15
K946103	Trustex Flavor Condon in Colors	Line One Laboratories & Trading Co.	HIS	Class II	1996-07-15
K962512	Boston Contact Lens Case	Polymer Technology Div. Wilmington Partners, L.P.	LRX	Class II	1996-07-12
K962355	Free Triiodothyronine(ft3) Assay for the Technicon Immuno 1 System (in-Vitro Diagnostic System)	Bayer Corp.	CDP	Class II	1996-07-12
K961619	Depuy Endurance Calcar Hip Prosthesis	Depuy, Inc.	JDI	Class II	1996-07-12
K961402	Sts Shield with Mask	Innovative Outsourcing Solutions	FXX	Class II	1996-07-12
K960803	Rx Textiles Sterile Stockinette	Paceline, Inc.	KKX	Class II	1996-07-12
K960669	Hydragel If, 6 If, 12 If Penta Kits/hydragel If, Double If, 2 If, & 4 If Kits	Morax	CFF	Class II	1996-07-12
K960258	Natural Hip System	Intermedics Orthopedics	JDI	Class II	1996-07-12
K960073	Ez-Personal Protection Kit with Spill Clean Up	Safetec of America, Inc.	FYA	Class II	1996-07-12
K960048	Ez-Personal Protection Kit with Spill Clean Up - Plus	Safetec of America, Inc.	FXX	Class II	1996-07-12
K954559	Howmedicca Modular Proximal Humerus Replacement System	Howmedica Corp.	HSD	Class II	1996-07-12
K962421	Sorbcel Alginate/cmc Wound Dressing	Innovative Technologies, Ltd.	KMF	Class I	1996-07-11
K962373	N/t Rheumatology Control Sl/1 and Sl/2	Behring Diagnostics, Inc.	DCK	Class II	1996-07-11
K962056	Advanced Micro-Osmometer Model 3300	Advanced Instruments, LLC	JJM	Class I	1996-07-11
K961758	Carasyn Hydrogel Wound Products	Carrington Laboratories, Inc.	MGQ	Unclassified	1996-07-11