510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150951Substantially Equivalent

aeris Balloon Dialation Catheter

Bryan Medical Inc, Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150951 is the FDA 510(k) clearance record for aeris Balloon Dialation Catheter, a class II device, cleared for Bryan Medical, 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 3 510(k) clearances for Bryan Medical, Inc., from to . As of , FDA records show one recall naming K150951.

Clearance record

Decision date
Received
(77 days to decision)
Product code
KTI Bronchoscope Accessory
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Bryan Medical, Inc. 3906 Oak St., Cincinnati OH
510(k) summary
Summary PDF
Third party review
Yes

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