# K984270: Vapo-Solution for Use in MDT Harvey Chemiclave Sterilizers, Models 5000, 5500, and 6000

- Pathway: 510(k) (Traditional)
- Applicant: Roger L. Goodman, D.D.S., P.C.
- Decided: May 20, 1999 after 171 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MDT Harvey Vapo-Steril® solution: named in the summary without a submission number

## Indications for use
Vapo Solution™ is an alcohol solution intended to be used only in Harvey Chemiclave sterilizers to sterilize medical and dental surgical instruments and equipment. Vapo Solution™ is intended to be a direct substitute for Vapo-Steril®. Vapo Solution™ is recommended for use in the following Chemiclave models: 4000, 5000, 5500, 6000, and models covered under K924380 and K943654. Vapo Solution™ is compatible with Chemiclave cycle parameters as follows: Model 4000, 5000, 5500, 6000, EMS500, EM5500, and EM6000 • Operating pressure: 20–40 psi (1.41–2.82 kg/cm²) • Operating Temperature: 132 ± 2 °C (270 ± 5 °F) • Maximum load: Bagged instruments: 6" Chamber (models 4000, 5000, EM5000) 0.6Kg (1.3lbs) 8" Chamber (models 5500, EM5500) 1.2Kg (2.6 lbs) 10" Chamber (models 6000, EM6000) 2.4Kg (5.3lbs) • Maximum load: Unwrapped instruments: 6" Chamber (models 4000, 5000, EM5000) 0.75Kg (1.7 lbs) 8" Chamber (models 5500, EM5500) 1.4Kg (3.1lbs) 10" Chamber (models 6000, EM6000) 2.8Kg (6.2lbs) Model 7000 and 8000 • Operating pressure: approximately 25 psi • Operating Temperature: 132 ± 2°C (270 ± 5°F) • Maximum load: Bagged instruments: 8" Chamber (model 7000) 1.2Kg (2.6lbs) 10" Chamber (model 8000) 2.4Kg (5.3lbs) • Maximum load: Unwrapped instruments: 8" Chamber (model 7000) 1.4 Kg (3.1lbs) 10" Chamber (model 8000) 2.8Kg (6.2lbs) Vapo Solution™ is compatible with but not limited to the following instruments and material types: • Surgical and cutting instruments, handpieces, and similar items • Plastics that can tolerate in excess of 132 °C, i.e. Polysulfone, Phenolic, Nylon, Teflon, Polyethylene, Polyester, Polypropylene. Note: Polycarbonate is not chemically compatible. • Rubber components made of Silicone, fluorosilicone Vapo Solution™ is not compatible with the following materials: • Linens, textiles or fabrics - These are incompatible with the chemical vapor process. • Liquids and agars - These are incompatible with high temperature processing (132°C). • Items contained in tightly woven packs or wraps, or sealed containers - These cause poor vapor penetration. • Plastics which cannot tolerate temperatures in excess of 132°C. • Polycarbonate - Chemically incompatible. • Nylon tubing and bags - Inhibits penetration of chemical vapors. Vapo Solution™ is not recommended for use for “flash” sterilization cycles.

Source page: https://510kreport.com/device/K984270
Methodology: https://510kreport.com/methodology