MiniCap 100 Capnometer
510(k) K883090
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883090 | Date30 Jan 1989 | 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- Withdrawn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
- Full name
- Minicap Tm 100 Capnometer
- 510(k) Number
- FDA Product Code
- CCK
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1400
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The MiniCap 100 Capnometer is a medical device classified as a capnometer, designed to measure exhaled carbon dioxide (CO₂) concentrations in respiratory gases. It provides real-time monitoring of end-tidal CO₂ levels, which are critical for assessing ventilation adequacy, particularly in anesthesia and critical care settings. The device supports clinical decision-making by offering precise capnographic waveforms and numerical readings, aiding in the management of patients under anesthesia or mechanical ventilation.
The MiniCap 100 is supplied as a reusable device and is intended for use in clinical environments such as operating rooms, intensive care units, and emergency departments. It requires proper calibration and maintenance per manufacturer instructions to ensure accurate performance. The device carries an FDA 510(k) clearance (K883090) under the Anesthesiology advisory committee, indicating regulatory compliance for its intended use. Storage and handling should follow standard medical device protocols to preserve functionality and sterility where applicable.
Other devices from Minesafety Appliances Co.
Questions
AI-generated answers, 1 Oct 2026
What is the MiniCap 100 Capnometer used for?
The MiniCap 100 Capnometer measures exhaled carbon dioxide (CO₂) concentrations in respiratory gases, specifically monitoring end-tidal CO₂ levels. This is critical for evaluating ventilation adequacy during anesthesia and in critical care settings, helping clinicians make informed decisions about patient management under anesthesia or mechanical ventilation.
Is the MiniCap 100 Capnometer reusable or single-use?
The MiniCap 100 Capnometer is designed as a reusable device. It is intended for use in clinical environments like operating rooms, intensive care units, and emergency departments, where proper calibration and maintenance per manufacturer instructions are required to ensure accurate performance and longevity.
How should the MiniCap 100 Capnometer be stored and handled?
The MiniCap 100 Capnometer should be stored and handled according to standard medical device protocols to maintain its functionality. Since it is reusable, it requires regular calibration and maintenance as specified by the manufacturer to ensure reliable operation and accuracy in clinical settings.
Does the MiniCap 100 Capnometer provide both waveform and numerical readings?
Yes, the MiniCap 100 Capnometer offers both precise capnographic waveforms and numerical readings. These features together enable clinicians to assess ventilation adequacy more comprehensively, supporting better decision-making during anesthesia and critical care procedures.
What regulatory clearance does the MiniCap 100 Capnometer hold?
The MiniCap 100 Capnometer holds FDA 510(k) clearance (K883090) under the Anesthesiology advisory committee, indicating it meets regulatory standards for its intended use in monitoring end-tidal CO₂ levels during anesthesia and critical care.