510k Device listing


Since there may be only one 510(k) holder for a specific device, if two entities list the same 510(k) number in the same annual listing period, FDA’s 510(k) database will show the person who listed their device most recently as the 510(k) holder.

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"only devices that do not differ significantly from the specifications described in a 510(k) (including conformity with a standard) are the subject of a substantial equivalence determination for the 510(k) and can be legally marketed based on that clearance. The 510(k) process applies to most Class II medical devices sold in the US and… All devices in this list are 510(k) exempt unless further qualified by a footnote. Sigma fda consultants in … Devices that do not have a required 510(k) clearance are adulterated and misbranded, and marketing an adulterated or misbranded device is a prohibited … In contrast to the PMA approval process, FDA requires that a product marketed via the 510(k) process demonstrate substantial equivalence to a predicate device or devices. A great example of the first scenario is how the FDA has looked at some recent design changes in the orthotics industry. It is formally called a Pre-market Notification.

In many cases manufacturers and distributors need to submit a 510k Premarket Notification or Premarket Approval document to the FDA, obtain market clearance, and follow and stay in compliance with QSR regulations when marketing and distributing products. FDA will contact both companies that listed the number and attempt to determine a single 510(k) holder. If your device falls into a generic category of exempted Class 1 devices as defined in 21 CFR Parts 862-892, a Premarket Notification 510(k) clearance may not be required unless you are introducing a new and unique technology, or unless you modify/change/exceed the intended use.

FDA Home; Medical Devices; Databases - Introduction. A 510(k) contains detailed technical, safety, and performance information about a medical device. A 510(k) is the technical dossier required by the US Food and Drug Administration (FDA) to sell a medium-risk medical device or IVD in the United States. Date Received: 11/05/2018: Decision Date: 03/07/2019: Decision: substantially equivalent (SESE) Regulation Medical Specialty: Cardiovascular 510k Review Panel Medical Device Exemptions 510(k) and GMP Requirements.

There are clauses in the regulation that void the 510(k) exemption, most notably if utilizing a new technology in a 510(k)-exempt device, or having a different intended use than what is commonly associated with the 510(k)-exempt device. The Device Listing process is completed by the FDA at no additional charge to the annual … For a new device to be deemed SE, it must be at least as safe and effective as the predicate. 510(k) Premarket Notification. The Device Listing process is completed by the FDA at no additional charge to the annual … Only devices annotated by *) are also exempt from GMP except … Eurotech providing 510 k approvals and registration of Medical devices with FDA, US agent, 510 K approvals, Registration and listing FDA regulatory consultant to help with FDA 510(k) clearance/approval for your medical device or IVD.

In order for a medical device to be sold in the U.S. market many of medical devices (most Class 2, some Class 1 and 3) are subject to FDA clearance called 510(k) submission process. FDA Home; Medical Devices; Databases - A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. If the situation cannot be resolved by FDA, the company …

Many companies have added …

Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class.

The documentation must demonstrate the device in question is "substantially equivalent" to a predicate …

Hi all! 510(k) Number: K180874: Device Name: 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield: Applicant: 3M Health Care: 3M Center, 2510 Conway Ave, Building 275-5W-06: st. paul, MN 55144 Applicant Contact: linda johnsen: Correspondent: 3M Health Care: 3M Health Care: 2510 Conway Ave, Building 275-5W-06: st. paul, MN 55144 Correspondent Contact: kristin …
A predicate device is a legally U.S. marketed device not subject to a PMA.

After your device has received the final FDA 510K clearance and approval, your newly approved device goes into the FDA device listings database as a FDA approved device. Re: Finding Medical Device Listing Numbers on the FDA site I am tasked with updating our contract manufacture status in our device listing on the FURLS site.