Reprocessed Blood Pressure Cuff
The reprocessed blood pressure cuff is a cardiovascular device used by trained personnel for manual measurement and automatic non-invasive blood pressure monitoring, representing a reprocessed version of a previously single-use cuff. It is classified as FDA Class 2 under regulation 870.1120 in the Cardiovascular specialty, requiring 510(k) clearance including reprocessing validation data. Product code NPP is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- NPP
- Device Class
- FDA class 2
- Regulation Number
- 870.1120
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
The intended use for the reprocessed/reused blood pressure cuff is use in manual measurement and automatic non-invasive blood pressure monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual bp measurement.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K032821 | HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF | Dec 05, 2003 | Substantially Equivalent | Hygia Health Services, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.