Avia Pain Medication Delivery System
510(k) K990312
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990312 | Date22 Apr 1999 | 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- Withdrawn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, 20 Sep 2026
The Avia Pain Medication Delivery System is a Pump, Infusion, PCA (Patient-Controlled Analgesia) device designed for the controlled delivery of pain medication. It falls under the FDA’s General Hospital classification and is classified as a Class 2 medical device. This system is engineered to administer medication directly to surgical incision sites, facilitating targeted pain relief in post-operative care settings.
Intended for single-patient, single-use in clinical environments, the system is operated by healthcare professionals. It is non-sterile as supplied and requires no special MRI safety considerations. The device is authorized under FDA 510(k) clearance (K990312) and adheres to regulatory requirements outlined under 21 CFR 880.5725. No third-party reprocessing is indicated, and storage conditions are manufacturer-specified.
Questions
AI-generated answers, 20 Sep 2026
What types of clinical settings is the Avia Pain Medication Delivery System designed for, and who operates it?
The Avia Pain Medication Delivery System is specifically designed for use in clinical environments, particularly for post-operative care where targeted pain relief is required at surgical incision sites. It is intended to be operated exclusively by healthcare professionals, ensuring safe and controlled administration of pain medication.
Is the Avia Pain Medication Delivery System intended for single-use or repeated use across multiple patients?
The Avia Pain Medication Delivery System is explicitly designed for single-patient, single-use only. This means each device is meant to be used once per patient and is not intended for reuse or reprocessing by third parties.
How should the Avia Pain Medication Delivery System be stored, and is it sterile as supplied?
The Avia Pain Medication Delivery System is non-sterile as supplied, meaning it requires additional sterilization or preparation before use in a clinical setting. Storage conditions are manufacturer-specified, so it is important to follow the provided guidelines to maintain its integrity and functionality.
What regulatory pathway was followed for FDA clearance of the Avia Pain Medication Delivery System?
The Avia Pain Medication Delivery System received FDA clearance through a Traditional 510(k) pathway under the classification of a Class 2 medical device (Pump, Infusion, PCA). It was determined to be substantially equivalent to a predicate device and falls under the General Hospital advisory committee category. The clearance number is K990312, and it adheres to regulatory requirements outlined under 21 CFR 880.5725.
Does the Avia Pain Medication Delivery System have any special considerations for use in MRI environments?
No, the Avia Pain Medication Delivery System does not require any special MRI safety considerations. This means it can be safely used in non-MRI environments without additional restrictions related to magnetic fields.