kBLASTER knows your time is money, so save it.

kBLASTER quickly finds predicates to fit your FDA 510(k) clearance strategy, but only kBLASTER can manage those results effectively with sorting, store 510(k)s with My Favorites and retain Saved Searches. kBLASTER routinely updates with new 510(k) summaries and automatically runs against your Saved Searches, sending Alert emails if Saved Search hits are found. All kBLASTER activity is captured with Search History, so you'll never lose any searches. kBLASTER is web browser based, so mobile devices or computers can be used interchangeably. Become your own data scientist with kBLASTER!


Click "Search Tips +" below to learn more about kBLASTER features.


Search Tips +

We've compiled a set of kBLASTER search tips below to enhance your experience.
Single Keyword Search

A Single keyword will search for a single term. Typing prostate will only show results that have the exact word prostate.

Multiple Keyword Search

Separate multiple keywords with a space so only files that match all of your search terms appear. Typing breast biopsy will show results that include the exact terms breast and biopsy anywhere in the summary. It is possible to link as many words as desired.

Exact Phrase Search

Place quotation symbols around a set of search terms so only files that match your exact phrase appear. Typing "breast biopsy" will only show results that include the exact phrase breast biopsy. It is possible to link an exact phrase with other exact phrases, other single or multiple keywords, or negation searches.

Negation Search

Use minus sign - to exclude results that match a keyword. Typing biopsy -needle will show results that match biopsy, but eliminate those that match needle. It is possible to exclude as many words separated by - as desired, but at least one desired keyword must be selected.

Partial Keyword Search

A partial keyword truncated with an asterisk will find results that have derivations of the word entered. Typing prostat* will show results for words that include prostat, such as prostate and prostatic.

Sort Search Results

By default, search results are sorted by "relevance".  Results with the greatest incidence of keywords will be displayed first. The sort order can be changed in the left sidebar. Search results can also be sorted by decision date or by 510(k) number.

510(k) Summary

Click 510(k) Summary below search hit to view available 510(k) summary at a separate window opened at FDA site. Link text will be orange if new to user and grey if clicked through previously. This function depends upon browser search history and clearing your search history will reset this feature.

510(k) Splash Page

Click 510(k) Splash Page below search hit to view 510(k) splash page at a separate window opened at FDA site. Link text will be orange if new to user and grey if clicked through previously. This function depends upon browser search history and clearing your search history will reset this feature.


To see if a recall exists for a 510(k), click on the 510(k) Splash Page.  If one does exist, there will be a live link for CDRH Recalls at bottom of splash page that takes you directly to information for that specific recall. 

De Novo Clearances

De novo clearances have moved from the standard 510(k) number identification convention to a DEN number identification method as of August 2014. These DEN number clearances are still viable predicates for future 510(k) submissions.

Add to Favorites

Click Add to Favorites below search hit to add a more pertinent search hit to your My Favorites folder.

View My Favorites

Your My Favorites folder can be accessed at the Search tab.

Save Search

Click Save Search in the left sidebar to save a set of search terms.

View Saved Searches

To view select Saved Searches link in Search tab or select a Most Recent Saved Searches in the menu in the left sidebar.

Saved Search Alert emails

kBLASTER will run saved searches periodically for recurring monthly customers and send an Alert email if a new Saved Search hit is found. If you receive an Alert email but your subscription has lapsed, resubscribe at the Buy page to revisit the Saved Search, then sort results by decision date to see the newest clearances.

Saved Search Notification Flags

In an active kBLASTER account, you’ll see a blue flag at Saved Searches on the Search tab indicating new Saved Search hits. Click Saved Searches at Search Tab to see Saved Searches with blue flags, or if in Most Recently Saved Searches, click blue flag hit at the left sidebar. To best view new hits indicated at flags, revisit the Saved Search and sort results by decision date to see the newest clearances.

Remove Flag on Saved Search

Once you've reviewed new hits flagged at Saved Search, go to the Saved Search and click Remove Flag. This clears the flag from the Saved Search, allowing for a new flag notification in the future with any new hits.

Delete Search

If you wish to delete a Saved Search, enter Saved Searches and click Delete Search. This will remove it from your Saved Search list, but not your Search History. 

View Search History

Click Search History at Search tab to access your entire search term history. The full Search History will be retained permanently for recurring monthly customers.