DeviceClearance

Product code CCK— Anesthesiology

Capnostream 35 Portable Respiratory Monitor

Classification name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device class
Class 2
Regulation
21 CFR 868.1400
Advisory panel
Anesthesiology
Total cleared
307
First cleared
Most recent

Market context for product code CCK

FDA has cleared 307 devices under product code CCK between 1977 and 2026, filed by 158 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code CCK

Adverse events under product code CCK

product code CCK
Death
3
Malfunction
11,428
Total
11,431

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code CCK

1–100 of 307

Data sourced from openFDA. This site is unofficial and independent of the FDA.