# K954736: Access (Powerclave)

- Pathway: 510(k) (Traditional)
- Applicant: Mdt Biologic Co.
- Decided: Aug 15, 1996 after 304 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K820783 (1982). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K820783: Castle Microcomputer Sterilizer Control, Sybron Corp. (1982) Summary page 1.

## Indications for use
The MDT Biologic Company Access (Powerclave) is an upgrade of an existing microcomputer control system intended to be used with hospital steam sterilizers. Specifically, Access (Powerclave) Steam Sterilizer Controls are to be used with “Castle” brand sterilizers manufacutered by MDT Biologic Company for use in industrial, laboratory, and health care facility environments. These sterilizers are intended to be used to sterilize wrapped and unwrapped surgical instruments, and liquids.

Source page: https://510kreport.com/device/K954736
Methodology: https://510kreport.com/methodology