Aldahol V High Level Disinfectant
by Microchem Laboratories, Inc.
510(k) K113015
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK113015 | Date30 Jan 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MED
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6885
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
Aldahol V High Level Disinfectant is a liquid chemical sterilant and high-level disinfectant, classified under FDA’s sterilant category (product code MED). It is designed to inactivate microorganisms, including mycobacteria, viruses, and spores, achieving high-level disinfection and sterilization through chemical means. The formulation leverages glutaraldehyde as its primary active ingredient, with isopropanol enhancing its mycobactericidal efficacy. This device is intended for use in environments requiring stringent decontamination, such as medical and dental facilities.
The product is supplied as a ready-to-use liquid and is regulated under FDA 510(k) clearance (K113015) with a traditional review pathway, classified as Class II. It is intended for single-use or reusable medical devices requiring high-level disinfection or sterilization, including endoscopes, surgical instruments, and other critical items. Storage and handling must comply with manufacturer guidelines to ensure efficacy and safety, though specific sterility or MRI safety data are not provided in the regulatory records. The device is authorized for use in general hospital settings as per FDA submissions.
Questions
AI-generated answers, 1 Oct 2026
What types of microorganisms does Aldahol V High-Level Disinfectant inactivate?
Aldahol V High-Level Disinfectant is formulated to inactivate a broad spectrum of microorganisms, including mycobacteria, viruses, and spores. The primary active ingredient, glutaraldehyde, provides sterilization-level efficacy, while isopropanol enhances its ability to kill mycobacteria specifically. This makes it suitable for high-level disinfection and sterilization of critical medical devices in environments requiring stringent decontamination, such as medical and dental facilities.
Is Aldahol V High-Level Disinfectant supplied ready-to-use, or does it require dilution?
Aldahol V High-Level Disinfectant is supplied as a ready-to-use liquid, eliminating the need for dilution before application. This convenience ensures immediate use for high-level disinfection or sterilization of reusable medical devices like endoscopes and surgical instruments, streamlining decontamination workflows in clinical settings.
Can Aldahol V High-Level Disinfectant be reused for multiple cycles?
The device is intended for use with both single-use and reusable medical devices requiring high-level disinfection or sterilization. However, the efficacy of the disinfectant itself depends on proper storage, handling, and adherence to manufacturer guidelines. Reuse of the disinfectant solution may require monitoring of its potency over time, as prolonged exposure or contamination could reduce its sterilizing capabilities.
What storage conditions are recommended for Aldahol V High-Level Disinfectant?
While specific storage details are not provided in the regulatory records, chemical sterilants like Aldahol V require protection from extreme temperatures, direct sunlight, and contamination to maintain efficacy. The manufacturer’s guidelines should be followed to ensure the solution remains effective for its intended use. Proper labeling and secure storage are critical to prevent misuse or degradation of the disinfectant.
Is Aldahol V High-Level Disinfectant approved for use in all medical specialties?
The FDA submission indicates Aldahol V High-Level Disinfectant is authorized for use in general hospital settings, as classified under the General Hospital advisory committee. While it is suitable for high-level disinfection and sterilization of critical devices, its applicability to specialized medical environments (e.g., dental, surgical subspecialties) should be confirmed by consulting the manufacturer’s instructions or additional regulatory documentation, as clinical workflows may vary.