Product Code: FKN
FDA class 2
21 CFR 876.5540
Adaptor, Shunt
Gastroenterology, Urology
The Shunt Adaptor is a connector used to interface blood tubing or other components with a vascular shunt used for hemodialysis access. It is classified as FDA Class 2 (moderate risk) and requires 510(k) premarket notification. The product code is FKN, regulated under 21 CFR 876.5540 in the Gastroenterology and Urology specialty. This device is flagged as an implant.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
11
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Basic Information
- Product Code
- FKN
- Device Class
- FDA class 2
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K893478 | DA-16 AND DA-24 SHUNT ADAPTERS | Jun 08, 1989 | Substantially Equivalent | Akcess Medical Products, Inc. |
| K892667 | SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313 | May 04, 1989 | Substantially Equivalent | Akcess Medical Products, Inc. |
| K813428 | SHUNT ADAPTER | Dec 31, 1981 | Substantially Equivalent | Quinton, Inc. |
| K771425 | A-V SHUNT EXTENSION | Jan 03, 1978 | Substantially Equivalent | Quinton, Inc. |