DeviceClearance

Product code CHL— Clinical Chemistry

ABL90 FLEX

Classification name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Device class
Class 2
Regulation
21 CFR 862.1120
Advisory panel
Clinical Chemistry
Total cleared
188
First cleared
Most recent

Market context for product code CHL

FDA has cleared 188 devices under product code CHL between 1976 and 2026, filed by 59 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 CHL

Adverse events under product code CHL

product code CHL
Death
20
Malfunction
999
Total
1,019

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 CHL

1–100 of 188

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