Get the free 510(k) Premarket Notification K093848 - accessdata fda

This document presents a premarket notification summary for the PT-Multi Calibrator, detailing its intended use, device description, establishment registration numbers, and compliance with FDA regulations

How to fill out 510k premarket notification k093848

How to fill out 510(k) Premarket Notification K093848

1. Identify the device you are seeking clearance for and ensure it is classified under a suitable regulation.
2. Gather all necessary documentation, including details about the device, manufacturing processes, and quality control measures.
3. Provide a description of the device and its intended use, highlighting its similarities to a legally marketed predicate device.
4. Conduct tests and provide results that demonstrate the device is safe and effective for its intended use.
5. Prepare the 510(k) submission form, ensuring all required information and data are included.
6. Submit the complete 510(k) Premarket Notification to the FDA along with any required fees.
7. Respond to any additional requests from the FDA during their review process.

Who needs 510(k) Premarket Notification K093848?

1. Manufacturers of medical devices that are similar to existing marketed devices and are seeking clearance to market their product in the U.S.
2. Companies looking to introduce changes to an already marketed device that might affect safety or effectiveness.
3. Any entity intending to sell or distribute medical devices classified by the FDA that require premarket notification.

People Also Ask about

What is a 510k device number?

Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the specific 510(k) number or product code associated with a given device.

What is the rejection rate for 510K?

The FDA 510(k) submission process is a critical gateway for medical device manufacturers seeking approval for their products in the United States. However, a concerning trend has emerged – a staggering 25% of these submissions are facing rejection due to lack of completeness.

How long does it take for the 510 K determination in the case of traditional premarket notification?

A 510(k) is a premarket submission made to the FDA. It is called a 510(k) because it refers to that section of the Food, Drug and Cosmetic Act. It is the regulatory pathway mostly utilized for Class II devices that hope to be substantially equivalent to another device which is currently legally marketed.

How long does 501k approval take?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

What is the difference between 510K and premarket approval?

What's the difference between a 510K vs PMA? 510(k) clearance is authorisation from the FDA to market a medium-risk medical device, while PMA (premarket approval) is required for more high-risk and novel products.

What is a 510 K premarket notification?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

How long will it take my 510 K to be cleared by the US FDA?

Once the FDA have received your submission, the FDA will officially start the clock on your decision timeline. At the time of writing the FDA states that a traditional 510(k) decision should be provided within 90 days.

For pdfFiller’s FAQs

What is 510(k) Premarket Notification K093848?

510(k) Premarket Notification K093848 is a document submitted to the FDA to demonstrate that a medical device is safe and effective and is substantially equivalent to a device already on the market.

Who is required to file 510(k) Premarket Notification K093848?

Manufacturers of medical devices that are classified as Class II or some Class I devices which require premarket submission are required to file 510(k) Premarket Notification K093848.

How to fill out 510(k) Premarket Notification K093848?

Filling out the 510(k) Premarket Notification K093848 involves several steps including gathering device information, identifying the predicate device, detailing device description and intended use, and submitting data on performance testing and labeling.

What is the purpose of 510(k) Premarket Notification K093848?

The purpose of 510(k) Premarket Notification K093848 is to provide the FDA with information to determine whether the device is substantially equivalent to an already marketed device, ensuring safety and effectiveness.

What information must be reported on 510(k) Premarket Notification K093848?

The information that must be reported includes the submitter's information, a description of the device, labeling, performance data, and any prior marketing history, as well as any safety and effectiveness data relevant to the device.