# K970726: Vapocide

- Pathway: 510(k) (Traditional)
- Applicant: Cottrell, Ltd.
- Decided: May 18, 1998 after 444 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. Our reading found no predicate number; beside “510(k)” the summary reads “2127197”, which our checks could not confirm as its predicate.
- (no number) Vapo-Steril: named in the summary without a submission number

## Indications for use
Vapocide® is a sterilant solution intended to be used only in the Harvey Chemiclave Sterilizer to sterilize medical and dental surgical instruments and equipment. Vapocide is intended to be a direct substitute for Vapo-Steril. Vapocide is recommended for use in the following Chemiclave models: Model E, 4000, 5000, 5500, 6000, 7000, 8000, and EM series sterilizers. Vapocide is compatible with Chemiclave cycle parameters as follows: Model E, 4000, 5000, 5500, 6000, EM 5000, EM 5500, EM 6000 • Operating pressure: 20-40 psi (1.41-2.82 kg/cm²) • Operating Temperature: 132±2°C (270±5°F) • Maximum load: 3.3 pounds (1.5 kg) for models with 9 and 10 in. diameter chambers Model 7000 and 8000 • Operating pressure: approximately 25 psi • Operating Temperature: 132 + 6, -0°C • Maximum load: 3.3 pounds (1.5 kg) Vapocide is compatible with but not limited to the following instruments and material types: • Surgical and cutting instruments, handpieces, and similar items • Plastic materials recommended are: Polysulfone, Phenolic, Epoxy, Polyphenylene oxide, Polyester, Polypropylene Note: Polycarbonate is not chemically compatible Vapocide™ is not compatible with the following materials: • Linen, textiles or fabrics • Liquids and agars • Items contained in tightly woven packs or wraps • Plastics that cannot tolerate temperature in excess of 132°C (270°F) • Nylon tubing & bags - inhibit penetration of chemical vapors Vapocide is not recommended for use for “flash” sterilization cycles.

Source page: https://510kreport.com/device/K970726
Methodology: https://510kreport.com/methodology