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FDA 510(k)

PADPRO MODEL #2516

K-Number: K020203 · 2002-05-08

ApplicantPadpro, LLC
Decision Date2002-05-08
Product CodeMKJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PADPRO MODEL #2516 is the device name listed in this FDA 510(k) record. The listed applicant is Padpro, LLC. It received FDA 510(k) clearance on 2002-05-08 under 510(k) number K020203. The device is classified under product code MKJ. It was reviewed by the CV advisory panel. Product code MKJ falls under the category of Dental, which includes dental instruments, materials, and equipment. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PADPRO MODEL #2516?

PADPRO MODEL #2516 is a medical device that received FDA 510(k) clearance on 2002-05-08. The listed applicant is Padpro, LLC. The 510(k) number is K020203.

When did PADPRO MODEL #2516 receive FDA 510(k) clearance?

PADPRO MODEL #2516 received FDA 510(k) clearance on 2002-05-08, under 510(k) number K020203.

Who is the listed applicant for PADPRO MODEL #2516?

The FDA 510(k) record lists Padpro, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PADPRO MODEL #2516?

The FDA product code for PADPRO MODEL #2516 is MKJ. This falls under the Dental category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Padpro, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K020743PADPRO, MODEL 2502K020288PADPRO, MODEL 2603K014209PADPRO MODEL 2001, 2001-S, 2001-C, 2001-EPSK003548PADPRO SYSTEM DEFIBRILLATOR ELECTRODE ADAPTERS

Related Devices (Code: MKJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131550HEART SYNCHeart Sync, Inc.K130684PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATORPhilips Medical SystemsK131494HEART SYNCHeart Sync, Inc.K130454LIFEPAK 20 DEFIBRILLATOR/MONITOR, LIFEPAK 20E DEFIBRILLATOR/MONITORPhysio-Control, Inc.K123881HEARTSINE SAMARITAN PAD 350PHeartsine Technologies, Inc.K130153HEARSTART MRX WITH AIRWAY CONFIMRATION ASSISTPhilips Medical Systems

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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