Product Code: HFO
FDA class 2
21 CFR 884.2700
Recorder, Pressure, Intrauterine
Obstetrics/Gynecology
The Intrauterine Pressure Recorder is a device that measures and records pressure within the uterine cavity, typically during labor, to document the pattern and intensity of uterine contractions for obstetric monitoring purposes. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HFO, regulated under 21 CFR 884.2700, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
4
Years Active
20
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Basic Information
- Product Code
- HFO
- Device Class
- FDA class 2
- Regulation Number
- 884.2700
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- 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 |
|---|---|---|---|---|
| K973850 | ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY #M007 | Nov 12, 1997 | Substantially Equivalent | Alexander Mfg. Co. |
| K943989 | LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENT | Sep 12, 1994 | Substantially Equivalent | Gabris Surgical Corp. |
| K791633 | UC-2000 UTERINE CATHERIZATION SYSTEM | Sep 17, 1979 | Substantially Equivalent | Life Support, Inc. |
| K780487 | FETAL MONITORING SYSTEM | May 09, 1978 | Substantially Equivalent | Sonicaid, Inc. |