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 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 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	2,669

176,466 records, page 2817 of 3530

510(k) clearances, page 2817 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K870572	Arrow-Clarke(tm) Pleura-Seal(tm) Thoracentesis Kit	Arrow Intl., Inc.	JOL	Class II	1987-05-26
K870451	Skin Graft Preservation Medium (Tissue)	Bioclinical Laboratory Services, Inc.	KIT	Class I	1987-05-26
K864282	Glucose Testcard Use W/ilex Prompt Clinical Ch Ana	Medical Device Consultants, Inc.	CGA	Class II	1987-05-26
K871819	Mcconnell Orthopedic Shoulder/hip Positioner	Mcconnell Orthopedic	FWZ	Class I	1987-05-22
K871752	Csf-Cardiac/peritoneal Catheter	Pudenz-Schulte Medical Research Corp.	JXG	Class II	1987-05-22
K871592	RF-1 Circuit	Diagnostic Imaging Specialists Corp.	IZH	Class II	1987-05-22
K871580	Implantable Pacing Lead Models 487-06 to 430-01	Intermedics, Inc.	DTB	Class III	1987-05-22
K871560	Baby E.t. Tape(tm)	B & B Medical Technologies, Inc.	CBH	Class I	1987-05-22
K871479	Videoscan (Tm)	Kera Corp.	HLQ	Class I	1987-05-22
K871425	Acs Enhanced-Torque Coronary Guiding Catheter	Advanced Cardiovascular Systems, Inc.	DQY	Class II	1987-05-22
K871384	Apex Suction Curette	Apex Medical, Inc.	GEA	Class I	1987-05-22
K871251	Circamed Full Disclosure System	Circadian, Inc.	DSI	Class II	1987-05-22
K871249	Kronner Bi-Planer Tibia External Fixation	Kronner Medical	KTT	Class II	1987-05-22
K871247	Kronner Universal Frame External Fixation	Kronner Medical	KTT	Class II	1987-05-22
K871104	Olympic Smart Scale	Olympic Medical Corp.	FRW	Class I	1987-05-22
K871047	Radiopaque Spherical Emboli (Rse)	Interventional Therapeutics Corp.	HCG	Class II	1987-05-22
K870962	Gesco Aspirator	Gesco Intl., Inc.	BSY	Class I	1987-05-22
K870839	Model 10-C W/fl-10A/u Optical Attachment/opthalmic	Directed Energy, Inc.	HQF	Class II	1987-05-22
K870421	Tdmac-Heparin Coated Rmi	Research Medical, Inc.	DWF	Class II	1987-05-22
K865056	Cui Tissue Expander Versafil(tm) Tissue Expander	Cox-Uphuff Intl.	LCJ	Unclassified	1987-05-22
K864387	Luxtec Fiberoptic Cables	Luxtec Corp.	EQH	Class I	1987-05-22
K871786	Gbna Medium	BD Becton Dickinson Vacutainer Systems Preanalytic	JSJ	Class I	1987-05-21
K871625	Model 366-12 Adaptaid (Tm) Step-Down Adapter	Intermedics, Inc.	DTB	Class III	1987-05-21
K871476	Silver Stain Reagent System	Sigma Chemical Co.	LEF	Class I	1987-05-21
K871342	Qm2/qm300 Control a Pack	Kallestad Diag, A Div. of Erbamont, Inc.	JJY	Class I	1987-05-21
K871341	Qm300 Calibrator a Pack	Kallestad Diag, A Div. of Erbamont, Inc.	JIX	Class II	1987-05-21
K871258	Biosurge Model Oasys	Biosurge, Inc.	CAC	Class II	1987-05-21
K871131	Sarns 9000 Heart-Lung Console	3M Health Care, Sarns	DTQ	Class II	1987-05-21
K871039	Stachrom Protein C Test Kit	American Bioproducts Co.	GGP	Class II	1987-05-21
K870926	C150-P ECG Cables	Desco Industries, Inc.	DPS	Class II	1987-05-21
K870357	Electrode, Pacemaker, Permanent & Temporary	Intermedics, Inc.	DTB	Class III	1987-05-21
K864877	Tri-Level Ligand Control	Ciba Corning Diagnostics Corp.	DHX	Class II	1987-05-21
K864681	Carhill One-Way Resuscitation Valve	Life Design Systems, Inc.	CBP	Class II	1987-05-21
K864618	Implantable Electrode Lead, Model 030-439	Telectronics, Inc.	DTB	Class III	1987-05-21
K864526	Endotracheal Tube Holder	Mathew Medical Co.	CBH	Class I	1987-05-21
K871791	Bloxom Irrigator	I.B. Bloxom C/O Hogan & Hartson	EXD	Class II	1987-05-20
K871702	Mrs Agar and Mrs Broth	BD Becton Dickinson Vacutainer Systems Preanalytic	JSJ	Class I	1987-05-20
K871701	Arylsulfatase Broth	BD Becton Dickinson Vacutainer Systems Preanalytic	JSH	Class I	1987-05-20
K871687	Tytem(r) Reagent Dispenser	Medical Laboratory Automation Systems, Inc.	JQW	Class I	1987-05-20
K871671	Urinoscopy Funnel	Portable Medical Laboratories, Inc.	GHO	Class I	1987-05-20
K871562	Ionocal	Foremost Dental Mfg., Inc.	EMA	Class II	1987-05-20
K871317	Follicle Stimulating Hormone (Hfsh)	Immuchem Corp.	CGJ	Class I	1987-05-20
K871224	Fast-Patch(tm)	Physio Control, Inc.	LDD	Class II	1987-05-20
K870751	Syntron Bioresearch Ez Check Hcg Pregnancy Test	Syntron Bioresearch, Inc.	JHI	Class II	1987-05-20
K870739	Abbott Testpack Hcg Combo	Abbott Medical	JHI	Class II	1987-05-20
K870230	Alloy for Dental Amalgam Luxalloy Non Gamma 2	Degussa Dental, Inc.	EJJ	Class II	1987-05-20
K865106	Prophylactic (Condom) Mr. Johnny	Medelec Intl. Corp.	HIS	Class II	1987-05-20
K864375	Type 316L Cotter Wire	Winn Hirsch & Assoc.	LRN	Class II	1987-05-20
K862122	S-Cal Hematology Calibrator	Coulter Electronics, Inc.	KRY	Class II	1987-05-20
K871805	Mcconnell Orthopedic Sterile Upright Support	Mcconnell Orthopedic	FWZ	Class I	1987-05-19