Prime PCA and PCA/Continuous Systems
by Prime Medical Products, Inc.
510(k) K920637
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK920637 | Date15 Jan 1993 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MEA
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5725
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Prime PCA and PCA/Continuous Systems are patient-controlled analgesia (PCA) infusion pumps designed for delivering continuous or on-demand intravenous analgesia. These devices facilitate precise dosing of pain medications, enabling patients to self-administer prescribed doses while healthcare providers maintain control over basal infusion rates and safety limits.
Intended for use in general hospital settings, these systems are classified as Class II medical devices under FDA regulations (880.5725) and have received a 510(k) clearance (K920637). The devices are reusable and require proper sterilization and maintenance as per manufacturer guidelines. No specific MRI safety information is provided, and their operation adheres to standard infusion pump protocols for patient safety and compliance.
Other devices from Prime Medical Products, Inc.
Questions
AI-generated answers, 19 Sep 2026
Are these PCA pumps designed for single-use or can they be reused in a clinical setting?
The Prime PCA and PCA/Continuous Systems are reusable devices. They require proper sterilization and maintenance as outlined by the manufacturer to ensure safe, repeated use in hospital settings. This design aligns with standard practices for infusion pumps in general hospital environments.
What types of pain management scenarios are these pumps intended for, and how do they differ from standard infusion pumps?
These pumps are specifically designed for patient-controlled analgesia (PCA), allowing patients to self-administer prescribed doses of pain medication while healthcare providers set basal infusion rates and safety limits. Unlike standard infusion pumps, they combine on-demand dosing (via patient activation) with continuous infusion capabilities, providing flexibility for acute pain management in general hospital settings.
How many different models or variations of these PCA pumps exist, and are they all compatible with each other?
The Prime PCA and PCA/Continuous Systems include multiple models, as indicated by the listed FEI numbers (e.g., 3010381606, 3002999813, etc.). While the exact specifications of each model aren’t detailed here, they are all classified under the same product code (MEA) and intended for general hospital use. Compatibility should be verified with the manufacturer, as variations may exist in functionality or connectivity.
What storage or handling requirements should be followed for these reusable PCA pumps before and after use?
Since these pumps are reusable, they must be properly sterilized and maintained between uses to prevent contamination and ensure reliability. The manufacturer provides guidelines for sterilization and care, which should be strictly followed. Storage should occur in a clean, dry environment away from direct sunlight or extreme temperatures to preserve functionality and safety.
How were these pumps evaluated for safety and equivalence to prior devices, and what regulatory pathway was followed?
The Prime PCA and PCA/Continuous Systems were cleared through the FDA’s 510(k) process, with a decision dated January 15, 1993, under the Traditional pathway. The submission was classified as Substantially Equivalent (SESE) to prior devices and falls under product code MEA, intended for general hospital use. The review was conducted by the Hospital/Orthopedic (HO) Advisory Committee, ensuring compliance with infusion pump safety standards.