Atlas FDA

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

Pentax Medical Company · Predicate Candidate Screening

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

112 daysmedian FDA review time
302 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K131946ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREPentax Medical Company2014-04-253020
K131028PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)Pentax Medical Company2014-04-103632
K131902PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)Pentax Medical Company2014-04-102892
K131855PENTAX VIDEO COLONOSCOPES (EC FAMILY)Pentax Medical Company2014-04-092922
K093037PENTEX EC-3890LIPentax Medical Company2009-12-28900
K092710PENTAX ED-3490TK, VIDEO DUODENOSCOPEPentax Medical Company2009-12-02901
K090197EG-3870UTKPentax Medical Company2009-05-191121
K090196EG-3670URKPentax Medical Company2009-05-191120
K081518ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UKPentax Medical Company2008-09-05980
K061068EG-3670URKPentax Medical Company2006-05-03160
K042741EC-3870CILK, CONFOCAL VIDEO COLONOSCOPEPentax Medical Company2004-10-19152
K042740ISC-1000 PENTAX CONFOCAL LASER SYSTEMPentax Medical Company2004-10-19150

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