Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Blue Sky Bio, LLC — Predicate Candidate Screening

16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

160 daysmedian FDA review time
302 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K232653Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue SkyBlue Sky Bio, LLC2024-04-032160
K221845Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Blue Sky Bio, LLC2023-02-242450
K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long ImpBlue Sky Bio, LLC2022-06-303020
K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC2020-12-181490
K201919Blue Sky Bio TADBlue Sky Bio, LLC2020-12-171600
K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC2019-08-121650
K180107Blue Sky Bio AlignerBlue Sky Bio, LLC2018-02-09240
K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC2016-04-291900
K112875BLUE SKY BIO DENTAL TAPER HEX IMPLANT SYSTEMSBlue Sky Bio, LLC2012-01-271190
K110198BLUE SKY BIO TCPBlue Sky Bio, LLC2011-12-223320
K102034BLUE SKY BIO DENTAL IMPLANT SYSTEMBlue Sky Bio, LLC2011-04-192740
K090607BLUE SKY BIO PLAN, VERSION .38Blue Sky Bio, LLC2009-04-22470
K073713BLUE SKY BIO DENTAL IMPLANT SYSTEMBlue Sky Bio, LLC2008-03-28880
K063874DRILL FOR BLUE SKY BIO DENTAL IMPLANT SYSTEMBlue Sky Bio, LLC2007-03-29900
K060957MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEMBlue Sky Bio, LLC2006-05-05280
K051507MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEMBlue Sky Bio, LLC2005-09-02870

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda