Hemawipe System
510(k) K884206
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884206 | Date18 Apr 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Hemawipe System, the Civilized Test
- 510(k) Number
- FDA Product Code
- KHE
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.6550
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Hemawipe System is a reagent-based device designed for the detection of occult blood in stool samples. Classified as a reagent for hematology, it is intended for use in laboratory settings to identify hidden blood, which may indicate gastrointestinal conditions such as ulcers, polyps, or colorectal cancer. The system leverages chemical reactions to provide a visual indication of blood presence, aiding in diagnostic evaluations.
Supplied as a single-use diagnostic tool, the Hemawipe System is regulated under FDA 510(k) clearance (K884206) and falls under product code KHE, adhering to 21 CFR 864.6550. It is intended for use in clinical laboratories and requires proper storage to maintain reagent integrity. The device is not MRI-compatible, and no information regarding sterility beyond single-use is provided in the regulatory data.