Atlas FDA

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

Neuro Supplies, Inc. — Predicate Candidate Screening

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

86 daysmedian FDA review time
224 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K991769CUTANEOUS (BAR) ELECTRODENeuro Supplies, Inc.1999-08-18860
K991771DIGITAL RING ELECTRDENeuro Supplies, Inc.1999-08-18860
K991770CUTANEOUS (GROUND) ELECTRODENeuro Supplies, Inc.1999-08-18860
K991772CUTANEOUS (DISC) ELECTRODENeuro Supplies, Inc.1999-08-18860
K942921NEUROLINK EEG/EP/EMG SURFACE ELECTRODESNeuro Supplies, Inc.1995-01-312240

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