Atlas FDA

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

Summit Doppler Systems, Inc. — Predicate Candidate Screening

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

50 daysmedian FDA review time
60 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K103693VANTAGE ABISummit Doppler Systems, Inc.2011-02-15600
K101816STN PROBESummit Doppler Systems, Inc.2010-08-19500
K093393LIFEDOP MODEL 300ABISummit Doppler Systems, Inc.2009-12-24550
K090499LIFEDOP MODEL, L350RSummit Doppler Systems, Inc.2009-03-31340
K063600VISTA AVSSummit Doppler Systems, Inc.2006-12-19150
K060410ECHOHEART TRANSVAGINAL DOPPLER PROBESummit Doppler Systems, Inc.2006-04-10530
K024197LIFEDOP DOPPLERSummit Doppler Systems, Inc.2003-01-03140

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