510(k) · Cleared
ClearedVapocide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cottrell, Ltd. · MED Sterilant, Medical Devices
Cleared on May 18, 1998 after a 444-day review. Our reading found no predicate number; beside “510(k)” the summary reads “2127197”, which our checks could not confirm as its predicate.
- Decided
- May 18, 1998
- Review
- 444 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 0
Our reading found no predicate number; beside “510(k)” the summary reads “2127197”, which our checks could not confirm as its predicate.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MED? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MED device
- #1 K251666 SYSTEM 1E Liquid Chemical Sterilant Processing…score 13.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Vapo-Steril Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MED devicesMED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MED
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MED
84in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MED
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MED
9in 2025
MAUDE reports naming product code MED, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 3 | 34 |
| 2008 | 1 | — | 2 | 79 |
| 2009 | 0 | — | 0 | 158 |
| 2010 | 6 | 281 | 0 | 89 |
| 2011 | 0 | — | 2 | 106 |
| 2012 | 3 | 111 | 0 | 337 |
| 2013 | 1 | — | 0 | 140 |
| 2014 | 1 | — | 0 | 105 |
| 2015 | 0 | — | 0 | 110 |
| 2016 | 1 | — | 0 | 135 |
| 2017 | 1 | — | 0 | 74 |
| 2018 | 2 | — | 0 | 42 |
| 2019 | 4 | 84 | 0 | 35 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 2 | — | 0 | 31 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 2 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (228 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970726 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970726: Vapocide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970726
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026