510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K813209Substantially Equivalent

Tracheobronchial Suction Catheter

Hydromer, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813209 is the FDA 510(k) clearance record for TRACHEOBRONCHIAL SUCTION CATHETER, a class I device, cleared for Hydromer, Inc. on under FDA product code BSY (Catheters, Suction, Tracheobronchial). FDA records list one 510(k) clearance for Hydromer, Inc. As of , FDA records show no recalls naming K813209.

Clearance record

Decision date
Received
(33 days to decision)
Product code
BSY Catheters, Suction, Tracheobronchial
Regulation
21 CFR 868.6810
Device class
Class I
Review panel
Anesthesiology
Applicant
Hydromer, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code BSY

Trailing 12 months

FDA records hold no clearances under product code BSY in the trailing twelve months.

FDA records show no clearances under product code BSY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BSY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260