# K014174: Harvey PV Dry Sterilizer, Model # ST127325; ST127320; ST127320-33

- Pathway: 510(k) (Traditional)
- Applicant: Barnstead/Thermolyne Corp.
- Decided: Feb 22, 2002 after 64 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 K924955 (1993). 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)
- K924955: MDT/Harvey MC-8 and MC-10, Mdt Corp., Inc. (1993) Summary page 1.

## Indications for use
The Harvey® PV Dry is a prevacuum and post vacuum drying sterilizer intended to provide sterilization of medical and dental instruments. It is intended to provide sterilization of wrapped or unwrapped metal instruments, surgical devices and other heat stable devices in pouches, surgical packs, dental handpieces, and linen packs. Deionized or distilled water is required for operation of the Harvey® PV Dry. The sterilizer has four standard cycles: Unwrapped Instruments (135C for 3 minutes); Wrapped Instrumeats (135C for five minutes); Packs (121C for 30 minute); Special, for dental handpieces (5 minutes at 134C). There is also an accessible Bowie-Dick test cycle for routine testing of the steam penetration capability into packs. The parameters are fixed for each cycle.

Source page: https://510kreport.com/device/K014174
Methodology: https://510kreport.com/methodology