FDA 510(k) clearance · back to tracker
Helo Return
Endovascular Engineering, Inc. cleared K253717 on 2026-10-11, decision: substantially equivalent
K-number
K253717
Sponsor
Endovascular Engineering, Inc.
Device
Helo Return
Class
Class II
Decision
Substantially Equivalent
Decision date
2026-10-11
Product code
SHJ
Advisory committee
Anesthesiology
Medical specialty
Anesthesiology
Regulation number
868.5830
Official FDA record
Open K253717on accessdata.fda.gov →
FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.
openFDA JSON
Raw record →
Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.
Use this as a predicate
Drop K253717 into Compass and start a substantial-equivalence draft.
Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.
Try the sandboxSource
Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.