Product Code: FJF
FDA class 2
21 CFR 876.5820
Detector, Air Bubble
Gastroenterology, Urology
The Air Bubble Detector is a safety device used in hemodialysis circuits to detect the presence of air or gas bubbles in the blood tubing, triggering an alarm and clamping the line to prevent air embolism in the patient. It is classified as FDA Class 2, requiring 510(k) premarket clearance, and is considered life-sustaining or life-supporting. The product code is FJF, regulated under 21 CFR 876.5820, within the Gastroenterology, Urology specialty.
510(k)s
5
FEI Numbers
0
Registration Numbers
0
Unique Applicants
5
Years Active
13
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Basic Information
- Product Code
- FJF
- Device Class
- FDA class 2
- Regulation Number
- 876.5820
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K904992 | MINNILERT AIR DETECTOR | Feb 05, 1991 | Substantially Equivalent | Minntech Corp. |
| K891327 | NICKLE-TITANIUM ORTHODONTIC WIRE | May 10, 1989 | Substantially Equivalent | American Orthodontics |
| K781330 | BLOOD LEVEL DETECTOR-MODEL 7601 | Aug 31, 1978 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K780582 | DETECTOR, BUBBLE & FOAM | Jun 22, 1978 | Substantially Equivalent | Hospal Medical Corp. |
| K770857 | DIALYSIS MACHINE, CENTRY II | Oct 04, 1977 | Substantially Equivalent | Cobe Laboratories, Inc. |