FDA 510(k) clearance · back to tracker
Heylo System
Coloplast Corp. cleared K252140 on 2025-10-06, decision: substantially equivalent
K-number
K252140
Sponsor
Coloplast Corp.
Device
Heylo System
Class
Class I
Decision
Substantially Equivalent
Decision date
2025-10-06
Product code
EXB
Advisory committee
Gastroenterology, Urology
Medical specialty
Gastroenterology, Urology
Regulation number
876.5900
Official FDA record
Open K252140on 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 K252140 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.