Atlas FDA

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

Welldoc, Inc. — Predicate Candidate Screening

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

125 daysmedian FDA review time
305 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K222888BlueStar CGM insulin dose calculatorWelldoc, Inc.2023-08-113220
K230813BlueStar and BlueStar RxWelldoc, Inc.2023-07-281260
K203434BlueStar RxWelldoc, Inc.2021-09-082890
K193654BlueStar RxWelldoc, Inc.2020-04-07990
K190013WellDoc BlueStarWelldoc, Inc.2019-11-043050
K162532WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc.2017-01-121250
K162225WellDoc BlueStar (WellDoc DiabetesManager System and DiabeteWelldoc, Inc.2016-11-221060
K141273WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTEWelldoc, Inc.2014-07-08530
K120314WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTWelldoc, Inc.2012-02-24230
K112370WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTWelldoc, Inc.2011-10-14580
K100066DIABETESMANAGER SYSTEM, DIABETESMANAGER-RX SYSTEM MODEL VERSWelldoc, Inc.2010-07-151850

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