DeviceClearance

Product code KTI— Ear, Nose, Throat

PeriView FLEX

Classification name
Bronchoscope Accessory
Device class
Class 2
Regulation
21 CFR 874.4680
Advisory panel
Ear, Nose, Throat
Total cleared
34
First cleared
Most recent

FDA classification definition

“If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).”

— U.S. Food and Drug Administration, device classification record for product code KTI under 21 CFR 874.4680, via openFDA

Market context for product code KTI

FDA has cleared 34 devices under product code KTI between 1978 and 2026, filed by 26 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 KTI

Adverse events under product code KTI

product code KTI
Malfunction
642
Total
642

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 KTI

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