510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213015Substantially Equivalent

DORA Disposable A.V. Fistula Needle Sets

Bain Medical Equipment(guangzhou) Co., Ltd., Guangzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213015 is the FDA 510(k) clearance record for DORA Disposable A.V. Fistula Needle Sets, a class II device, cleared for Bain Medical Equipment (Guangzhou) Co., Ltd. on under FDA product code FIE (Needle, Fistula). FDA records list 7 510(k) clearances for Bain Medical Equipment (Guangzhou) Co., Ltd., from to . As of , FDA records show no recalls naming K213015.

Clearance record

Decision date
Received
(200 days to decision)
Product code
FIE Needle, Fistula
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Bain Medical Equipment (Guangzhou) Co., Ltd. #10, Juncheng Rd., Eastern Area, Economic And, Guangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FIE

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