510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863497Substantially Equivalent

Suction Catheter Kit

Welmed Systems, Inc., West Swanzey NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863497 is the FDA 510(k) clearance record for SUCTION CATHETER KIT, a class I device, cleared for Welmed Systems, Inc. on under FDA product code BSY (Catheters, Suction, Tracheobronchial). FDA records list 7 510(k) clearances for Welmed Systems, Inc., from to . As of , FDA records show no recalls naming K863497.

Clearance record

Decision date
Received
(27 days to decision)
Product code
BSY Catheters, Suction, Tracheobronchial
Regulation
21 CFR 868.6810
Device class
Class I
Review panel
Anesthesiology
Applicant
Welmed Systems, Inc. P.O. Box 599, West Swanzey NH
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