510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220730Substantially Equivalent

allFlex Ureteral Catheters, Krait Ureteral Catheters

Allwin Medical Devices, Inc., Anaheim CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K220730 is the FDA 510(k) clearance record for allFlex Ureteral Catheters, Krait Ureteral Catheters, a class II device, cleared for Allwin Medical Devices, Inc. on under FDA product code KOD (Catheter, Urological). FDA records list 7 510(k) clearances for Allwin Medical Devices, Inc., from to . As of , FDA records show no recalls naming K220730.

Clearance record

Decision date
Received
(213 days to decision)
Product code
KOD Catheter, Urological
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Allwin Medical Devices, Inc. 3305 E. Mira Loma Ave., Suite 176, Anaheim CA
510(k) summary
Statement
Third party review
No

Clearances, product code KOD

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