510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101214Substantially Equivalent

Guardian Connection

Maulin Medical, LLC, Pueblo West CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101214 is the FDA 510(k) clearance record for GUARDIAN CONNECTION, a class II device, cleared for Maulin Medical, LLC on under FDA product code FPD (Tube, Feeding). FDA records list one 510(k) clearance for Maulin Medical, LLC. As of , FDA records show no recalls naming K101214.

Clearance record

Decision date
Received
(84 days to decision)
Product code
FPD Tube, Feeding
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Maulin Medical, LLC 486 E. Gentry Dr., Pueblo West CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FPD

Trailing 12 months

FDA records hold no clearances under product code FPD in the trailing twelve months.

FDA records show no clearances under product code FPD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FPD, 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