PAO Value
510(k) K852990
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852990 | Date20 Sep 1985 | 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- Withdrawn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
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The PAO Value is a Peritoneal Access Outlet (PAO), a device classified under FDA product code FMF, designed for use in peritoneal dialysis procedures. It facilitates the controlled drainage and infusion of dialysis fluid within the peritoneal cavity, ensuring efficient fluid exchange while minimizing contamination risk. Constructed for single-use applications, it integrates with peritoneal dialysis systems to maintain sterile conditions during treatment.
Supplied as a sterile, single-use device, the PAO Value is intended for use in general hospital settings and is regulated under FDA 510(k) clearance (K852990). It adheres to traditional clearance pathways and is categorized under the General Hospital advisory committee. No additional regulatory markings or MRI safety classifications are specified in the available data. Storage and handling instructions are not provided, but compliance with standard sterile medical device protocols is implied.
Other devices from Ackard Laboratories
Questions
AI-generated answers, 1 Oct 2026
What is the PAO Value used for?
The PAO Value is designed specifically for peritoneal dialysis procedures. It serves as a Peritoneal Access Outlet (PAO) to facilitate the controlled drainage and infusion of dialysis fluid within the peritoneal cavity. This ensures efficient fluid exchange while minimizing the risk of contamination, which is critical for maintaining patient safety during treatment.
Is the PAO Value intended for single-use or reuse?
The PAO Value is explicitly designed for single-use applications. This design choice helps maintain sterile conditions during peritoneal dialysis, reducing the risk of cross-contamination between patients or procedures. Single-use devices are also aligned with best practices for infection control in medical settings.
What regulatory pathway does the PAO Value follow?
The PAO Value is regulated under the FDA’s 510(k) clearance pathway, specifically with clearance number K852990. It is classified under product code FMF and follows a traditional clearance process. The device was reviewed by the General Hospital advisory committee (HO) and is intended for use in general hospital settings.
How should the PAO Value be stored?
While specific storage instructions are not detailed in the available data, the PAO Value is supplied as a sterile, single-use device. As such, it should be stored in accordance with standard sterile medical device protocols to preserve its integrity and sterility until use. This typically includes keeping it in a clean, dry environment, away from direct sunlight or extreme temperatures.
Does the PAO Value have any special handling requirements?
The PAO Value is intended for sterile use in peritoneal dialysis, so adherence to sterile handling practices is essential. Since it is single-use, it should not be reused or reprocessed. Clinicians should follow general sterile medical device protocols, including proper packaging handling and avoiding contamination before use. No additional regulatory markings or special handling instructions beyond standard sterile device practices are specified.