Atlas FDA

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

Mauna Kea Technologies — Predicate Candidate Screening

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

88 daysmedian FDA review time
267 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K220477Cellvizio 100 series system with confocal MiniprobesMauna Kea Technologies2022-04-11520
K212322Cellvizio I.V.E. system with Confocal MiniprobesMauna Kea Technologies2021-08-18230
K193416Cellvizio I.V.E. with Confocal MiniprobesMauna Kea Technologies2020-02-28810
K191144Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies2020-01-242690
K183640Cellvizio 100 Series Confocal laser Imaging systems and theiMauna Kea Technologies2019-02-22580
K180270Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies2018-05-221110
K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies2017-12-15870
K171345Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies2017-08-04880
K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (Mauna Kea Technologies2016-05-20940
K150831Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies2015-12-222670
K151593Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies2015-10-231330
K141358CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBESMauna Kea Technologies2014-09-251250
K133466CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)Mauna Kea Technologies2014-07-252550
K123676CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINMauna Kea Technologies2013-04-181390
K122042CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINMauna Kea Technologies2012-09-04540
K120208CELLVIZIO 100 SERIES SYSTEM AND CELLVIZIO SYSTEM WITH CONFOCMauna Kea Technologies2012-04-20870
K061666CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX ANMauna Kea Technologies2006-08-24710
K051585F-400 SYSTEMMauna Kea Technologies2005-09-06830

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