510(k) · Cleared
ClearedVapo-Solution for Use in MDT Harvey Chemiclave Sterilizers, Models 5000, 5500, and 6000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roger L. Goodman, D.D.S., P.C. · MED Sterilant, Medical Devices
Cleared on May 20, 1999 after a 171-day review. The FDA summary names its predicate without a number.
- Decided
- May 20, 1999
- Review
- 171 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 |
|---|---|---|---|
| * | — | MDT Harvey Vapo-Steril® solution 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?
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…
Read the full statement (350 words)
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.
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/K984270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984270: Vapo-Solution for Use in MDT Harvey Chemiclave Sterilizers, Models 5000, 5500, and 6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984270
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026