510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K161392Substantially Equivalent

Elation Pulmonary Balloon Dilation

Merit Medical Systems, Inc., South Jordan UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161392 is the FDA 510(k) clearance record for Elation Pulmonary Balloon Dilation, a class II device, cleared for Merit Medical Systems, Inc. on under FDA product code KTI (Bronchoscope Accessory). FDA's definition for product code KTI reads: "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...". FDA records list 204 510(k) clearances for Merit Medical Systems, Inc., from to . As of , FDA records show no recalls naming K161392.

Clearance record

Decision date
Received
(105 days to decision)
Product code
KTI Bronchoscope Accessory
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Merit Medical Systems, Inc. 1600 W. Merit Pkwy., South Jordan UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KTI

Trailing 12 months
4 clearances under product code KTI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KTI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260