News

kBLASTER database update February 2014--Find your primary predicate for a successful 510(k) submission fast

Submitted by kBLASTER Team on

The kBLASTER database has been updated today with summaries for 510(k)s cleared in November and December 2013, as well as FDA splash pages from 510(k)s cleared in November/December 2013 and January 2014. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will shortly be seeing blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s). 

With more than 58,000 510(k) summaries to choose from, including more than 76,000 splash pages, find your best single...

kBLASTER database update November 2013--Find your primary predicate for a successful 510(k) submission fast

Submitted by kBLASTER Team on

The kBLASTER database has been updated today with 510(k)s cleared in September and October 2013, as well as FDA splash pages from 510(k)s cleared in September, October and November 2013. If you have Saved Searches in your kBLASTER account that meet the parameters of today's imports into the kBLASTER database, you will shortly be seeing blue notification flags in your active kBLASTER account on those Saved Searches, as well as Alert email(s). 

With more than 57,000 510(k) summaries to choose from, including more than 75,000 splash pages, find your best single primary...

kBLASTER database update October 2013--Find your primary predicate for a successful 510(k) submission fast

Submitted by kBLASTER Team on

The kBLASTER database has been updated today with 510(k) summaries from 510(k)s cleared in August, as well as FDA splash pages from 510(k)s cleared in August 2013 and September 2013. If you have Saved Searches in your kBLASTER account that meet the parameters of any of the October 7th imports into the kBLASTER database, you will be seeing Alert email(s) in the near future, if you haven't already.

With more than 57,000 510(k) summaries to choose from, including more than 75,000 splash pages, find your best single primary predicate fast, saving you time and money on the path to a...

kBLASTER database update August 2013--Find your primary predicate for a successful 510(k) submission fast

Submitted by kBLASTER Team on

The kBLASTER database has been updated today with 510(k) summaries from 510(k)s cleared in June and July, as well as FDA splash pages from 510(k)s cleared in June 2013, July 2013 and August 2013. If you have Saved Searches in your kBLASTER account that meet the parameters of any of the August 23rd imports into the kBLASTER database, you will be seeing Alert email(s) in the near future, if you haven't already.

With more than 57,000 510(k) summaries to choose from, including more than 75,000 splash pages, find your best single primary predicate fast, saving you time and money on...

kBLASTER database update June 2013--Find your primary predicate for a successful 510(k) submission fast

Submitted by kBLASTER Team on

The kBLASTER database has been updated today with 510(k) summaries from 510(k)s cleared in May, as well as FDA splash pages from 510(k)s cleared in May 2013 and June 2013. If you have Saved Searches in your kBLASTER account that meet the parameters of any of the June 28th imports into the kBLASTER database, you will be seeing Alert email(s) in the near future, if you haven't already.

With more than 57,000 510(k) summaries to choose from, including more than 75,000 splash pages, find your best single primary predicate fast, saving you time and money on the path to a successful 510...

kBLASTER database update May 2013--Find your primary predicate for a successful 510(k) submission fast

Submitted by kBLASTER Team on

The kBLASTER database has been updated today with 510(k) summaries from 510(k)s cleared in April, as well as FDA splash pages from 510(k)s cleared in April 2013 and May 2013. If you have Saved Searches in your kBLASTER account that meet the parameters of any of the May 20th imports into the kBLASTER database, you will be seeing Alert email(s) in the near future, if you haven't already.

With more than 56,000 510(k) summaries to choose from, including more than 74,000 splash pages, find your best single primary predicate fast, saving you time and money on the path to a successful...

kBLASTER database update April 2013--Find your primary predicate for a successful 510(k) submission fast

Submitted by kBLASTER Team on

The kBLASTER database has been updated today with 510(k) summaries from 510(k)s cleared in March 2013, as well as FDA splash pages from 510(k)s cleared in March 2013 and April 2013. If you have Saved Searches in your kBLASTER account that meet the parameters of any of the April 19th imports into the kBLASTER database, you will be seeing Alert email(s) in the near future, if you haven't already.

With more than 56,000 510(k) summaries to choose from, including more than 74,000 splash pages, find your best single primary predicate fast, saving you time and money on the path to a...

kBLASTER database update March 2013--Find your primary predicate for a successful 510(k) submission fast

Submitted by kBLASTER Team on

The kBLASTER database has been updated today with 510(k) summaries from 510(k)s cleared in February 2013, as well as FDA splash pages from 510(k)s cleared in February 2013 and March 2013. If you have Saved Searches in your kBLASTER account that meet the parameters of any of the February 14th imports into the kBLASTER database, you will be seeing Alert email(s) in the near future, if you haven't already.

With more than 56,000 510(k) summaries to choose from, including more than 74,000 splash pages, find your best single primary predicate fast, saving you time and money on the path...

kBLASTER database update February 2013--Find your primary predicate for a successful 510(k) submission fast

Submitted by kBLASTER Team on

The kBLASTER database has been updated today with 510(k) summaries from 510(k)s cleared in January 2013, as well as FDA splash pages from 510(k)s cleared in January 2013 and February 2013. If you have Saved Searches in your kBLASTER account that meet the parameters of any of the February 14th imports into the kBLASTER database, you will be seeing Alert email(s) in the near future, if you haven't already.

With more than 56,000 510(k) summaries to choose from, including more than 74,000 splash pages, find your best single primary predicate fast, saving you time and money on the...

Updated Final Guidance – Refuse to Accept Policy for 510(k)s

Submitted by kBLASTER Team on

This final FDA guidance document published on December 31, 2012 and contains nonbinding recommendations regarding an FDA checklist for refusal to accept 510(k)s. This guidance document includes nine instances of predicate requirements within this checklist for 510(k)s, along with numerous other items on the checklist. This revised draft supercedes the draft guidance published on August 13, 2012....

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