Atlas FDA

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

Fiab Spa — Predicate Candidate Screening

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

136 daysmedian FDA review time
304 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K192210ESOTEST MULTI Esophageal Temperature Probe and Temperature MFiab Spa2019-10-10570
K180047ESOTEST MULTI Esophageal Temperature Probe and Temperature MFiab Spa2018-11-083040
K123361ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORFiab Spa2013-02-271190
K103783EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT:Fiab Spa2011-06-161710
K100333FIAB SPA, MODELS F7244, F7233, F7234, F7277Fiab Spa2010-06-211360
K083428F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BAFiab Spa2009-09-012860
K091163PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PGFiab Spa2009-07-22910

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