K252140 is an FDA 510(k) clearance for the Heylo™ System. This device is classified as a Collector, Ostomy (Class I - General Controls, product code EXB).
Submitted by Coloplast Corp. (Plymouth, US). The FDA issued a Cleared decision on October 6, 2025, 90 days after receiving the submission on July 8, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5900.
| 510(k) Number | K252140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2025 |
| Decision Date | October 06, 2025 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EXB — Collector, Ostomy |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.5900 |