510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180115Substantially Equivalent

TWBM Pump

TAIWAN BIOMATERIAL Company, Ltd., Zhubei, TW / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180115 is the FDA 510(k) clearance record for TWBM Pump, a class II device, cleared for Taiwan Biomaterial Co., Ltd. on under FDA product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered). FDA records list 2 510(k) clearances for Taiwan Biomaterial Co., Ltd., from to . As of , FDA records show no recalls naming K180115.

Clearance record

Decision date
Received
(189 days to decision)
Product code
JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Regulation
21 CFR 878.4780
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Taiwan Biomaterial Co., Ltd. 6f, # 26-1, Sec.2, Shengyi Rd., Zhubei, TW
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JCX

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