Pressure Monitoring Injection Lines
510(k) K781558
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781558 | Date10 Oct 1978 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DQO
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1200
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Pressure Monitoring Injection Lines are sterile, single-use medical devices designed for intravenous administration and pressure monitoring in clinical settings. These lines facilitate the delivery of fluids, medications, or blood products while enabling real-time pressure assessment, ensuring accurate infusion rates and patient safety during procedures.
Intended for use in hospital environments, these lines are supplied as sterile, disposable components and must be used once before disposal. They are classified under FDA 510(k) clearance (K781558) and fall under the product code DQO, regulated by the Cardiovascular Advisory Committee. Compliance with sterile packaging and single-use guidelines is mandatory to prevent contamination and ensure proper functionality.
Other devices from Cobe Laboratories, Inc.
Questions
AI-generated answers, 1 Oct 2026
What are the Pressure Monitoring Injection Lines used for?
These lines are designed for intravenous administration of fluids, medications, or blood products while simultaneously enabling real-time pressure monitoring. This dual functionality ensures accurate infusion rates and helps maintain patient safety during critical procedures by detecting pressure variations that could indicate issues like occlusion or improper flow.
Are the Pressure Monitoring Injection Lines reusable or single-use?
The Pressure Monitoring Injection Lines are strictly single-use devices. This design prevents contamination and ensures consistent performance, as reuse could compromise sterility and functionality. After use, they must be discarded to comply with medical device safety standards.
How are these lines supplied, and what does sterility mean in this context?
The lines are supplied as sterile, disposable components in sealed packaging. Sterility in this context means they are manufactured under controlled conditions to eliminate harmful microorganisms, ensuring they are safe for direct contact with a patient’s vascular system without risk of infection. The sterile packaging must remain intact until immediate use.
What regulatory pathway does this device follow, and why does it matter?
The Pressure Monitoring Injection Lines follow the FDA’s 510(k) clearance pathway, specifically under clearance number K781558, and are classified under product code DQO. This pathway ensures the device meets established safety and effectiveness standards by demonstrating substantial equivalence to a legally marketed predicate device. Compliance with this regulatory route guarantees clinical reliability and adherence to U.S. medical device regulations.
How should these lines be stored before use?
The sterile packaging must be kept unopened and protected from physical damage, moisture, or contamination until immediate use. Storage should follow manufacturer guidelines, typically in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures the device remains sterile and functional, maintaining its integrity for safe clinical application.