510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K140228Substantially Equivalent

Disposable Tracheal Tube

Suzhou Weikang Medical Apparatus Co., Ltd., Guangzhou, Guangdong, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140228 is the FDA 510(k) clearance record for DISPOSABLE TRACHEAL TUBE, a class II device, cleared for Suzhou Weikang Medical Apparatus Co., Ltd. on under FDA product code BTR (Tube, Tracheal (W/Wo Connector)). FDA records list 2 510(k) clearances for Suzhou Weikang Medical Apparatus Co., Ltd., from to . As of , FDA records show no recalls naming K140228.

Clearance record

Decision date
Received
(322 days to decision)
Product code
BTR Tube, Tracheal (W/Wo Connector)
Regulation
21 CFR 868.5730
Device class
Class II
Review panel
Anesthesiology
Applicant
Suzhou Weikang Medical Apparatus Co., Ltd. 7th Floor Jingui Business Buidling # 982, Guangzhou, Guangdong, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BTR

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