Gem-Crit Check
by Diamond Sensor Systems 510(k)
Active
510(k) K871686
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK871686 | Date18 Jun 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DRY
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Gem-Crit Check is a Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass device. It is substantially equivalent to a predicate device and was cleared via the traditional 510(k) pathway.
It is manufactured by Diamond Sensor Systems and authorized under FDA 510(k) clearance K871686. The device is classified as Class II and falls under regulation number 870.4330 with product code DRY. It is intended for cardiovascular applications.
Other devices from Diamond Sensor Systems
Questions
AI-generated answers, 25 Sep 2026
What is the Gem-Crit Check used for?
The Gem-Crit Check is intended for cardiovascular applications as an on-line blood-gas monitor during cardiopulmonary bypass procedures, providing real-time monitoring of blood gas parameters to support patient management during surgery.
How is the Gem-Crit Check supplied and is it reusable?
The Gem-Crit Check is a monitor device designed for repeated use in clinical settings; it is not a single-use disposable item but rather a reusable monitoring system that requires proper cleaning and maintenance between uses according to manufacturer guidelines.
What regulatory pathway was used for the Gem-Crit Check?
The Gem-Crit Check was cleared via the traditional 510(k) pathway under FDA authorization K871686, demonstrating substantial equivalence to a predicate device in the same product code and regulation.