Atlas FDA

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

Spes Medica Srl — Predicate Candidate Screening

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

128 daysmedian FDA review time
505 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K211954Subdural Electrode, Strip/Intraoperative Strip, Grid/IntraopSpes Medica Srl2022-11-105050
K212326AC Cream - Conductive pasteSpes Medica Srl2021-12-011280
K192606SAC2 - Electrode CreamSpes Medica Srl2020-01-171190
K192603Spes Medica Subdermal Needle ElectrodesSpes Medica Srl2019-11-22630
K190050Tech Dots - Adhesive and conductive gelSpes Medica Srl2019-07-191900
K133348STIM PROBESpes Medica Srl2014-11-213870
K120494DISPOSABLE ADHESIVE SURFACE ELECTRODESpes Medica Srl2012-06-111150
K093373LARYNGEAL SURFACE ELECTRODESpes Medica Srl2010-08-242990
K091410DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOTSpes Medica Srl2009-08-11900

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