Device, Bleeding Time
A bleeding time device is a standardized instrument used to make a small, controlled incision in the skin, typically the forearm, to measure the time required for bleeding to stop, providing an in vivo assessment of primary hemostasis and platelet plug formation. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is JCA, regulated under 21 CFR 864.6100, within the Hematology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- JCA
- Device Class
- FDA class 2
- Regulation Number
- 864.6100
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K911745 | SIMPLATE PEDIATRIC | Aug 09, 1991 | Substantially Equivalent | Organon Teknika Corp. |
| K911996 | SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION | Jul 17, 1991 | Substantially Equivalent | International Technidyne Corp. |
| K871318 | Q.I.C. BLEEDING TIME DEVICE | Jun 10, 1987 | Substantially Equivalent | Helena Laboratories |
| K850542 | SURGICUTT - BLEEDING TIME DEVICE | Mar 01, 1985 | Substantially Equivalent | International Technidyne Corp. |
| K830645 | BLEEDING TIME DEVICE DISPOSABLE | Mar 17, 1983 | Substantially Equivalent | American Dade |
| K801815 | AUTOLET | Oct 10, 1980 | Substantially Equivalent | Ulster Scientific, Inc. |
| K761250 | SIMPLATE | Mar 01, 1977 | Substantially Equivalent | General Diagnostics |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.