NormCap CD-102 Carbon Dioxide Analyzer
510(k) K801083
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801083 | Date28 May 1980 | 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- Withdrawn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
- CCL
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1720
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The NormCap CD-102 is a Carbon Dioxide Analyzer, designed to measure and monitor carbon dioxide levels in gaseous samples. It is classified as a Class II medical device under FDA regulation 868.1720 and falls under the category of gas analyzers used in gaseous-phase analysis. This device is intended for precise measurement of CO₂ concentrations, critical in clinical settings such as anesthesia and respiratory care.
The NormCap CD-102 is supplied as a reusable device and has received FDA 510(k) clearance (K801083) under the Traditional pathway, with a decision of Substantially Equivalent (SESE). It is intended for use in anesthesiology settings and is regulated under the advisory committee for Anesthesiology. The device is not specified as MRI-safe or single-use in the provided data. No additional sterility or storage requirements are mentioned beyond standard medical device handling.
Other devices from Instrumentarium-Datex
Questions
AI-generated answers, 19 Sep 2026
Is the NormCap CD-102 designed for single-use or can it be reused in clinical settings?
The NormCap CD-102 is explicitly described as a reusable device in the provided data. Since it is not labeled as single-use, it is intended for repeated use in clinical environments, provided standard medical device maintenance and cleaning protocols are followed. No additional sterility requirements beyond typical handling are mentioned.
What clinical specialties is the NormCap CD-102 primarily intended for, and how does this relate to its regulatory classification?
The NormCap CD-102 is primarily intended for use in anesthesiology, as indicated by its regulatory filing under the Anesthesiology advisory committee (AN) and its classification as a Class II medical device under FDA regulation 868.1720. This classification aligns with its role in monitoring carbon dioxide levels during anesthesia procedures, where precise gaseous-phase analysis is critical.
How was the NormCap CD-102’s regulatory pathway determined, and what does this mean for its market introduction?
The NormCap CD-102 received FDA 510(k) clearance (K801083) under the Traditional pathway, with a decision of Substantially Equivalent (SESE). This means the device was compared to a legally marketed predicate and determined to have the same intended use and technological characteristics, allowing it to enter the market without requiring a new breakthrough review. The clearance was granted in 1980, indicating its long-standing regulatory approval.
Are there any specific storage requirements mentioned for the NormCap CD-102, or should it be handled like standard reusable medical devices?
The provided data does not specify any unique storage requirements beyond what is standard for reusable medical devices. As a reusable analyzer, it should be stored in a clean, dry environment, protected from physical damage or contamination, and maintained according to manufacturer guidelines to ensure accurate CO₂ measurements in clinical settings.
What types of gaseous-phase analysis does the NormCap CD-102 perform, and how does this differ from other gas analyzers?
The NormCap CD-102 is specialized for precise measurement of carbon dioxide (CO₂) concentrations in gaseous samples, making it distinct from broader gas analyzers. While other analyzers may measure multiple gases (e.g., oxygen, nitrous oxide), this device is dedicated to CO₂ monitoring, which is essential in anesthesiology for assessing patient ventilation and metabolic function during procedures.