510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221452Substantially Equivalent

DiLumen C1, EZ1 and Tool Mount

Lumendi, LLC, Westport CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221452 is the FDA 510(k) clearance record for DiLumen C1, EZ1 and Tool Mount, a class II device, cleared for Lumendi, LLC on under FDA product code FDF (Colonoscope And Accessories, Flexible/Rigid). FDA's definition for product code FDF reads: "To examine or perform procedures in the colon or rectum For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807...". FDA records list 8 510(k) clearances for Lumendi, LLC, from to . As of , FDA records show no recalls naming K221452.

Clearance record

Decision date
Received
(268 days to decision)
Product code
FDF Colonoscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Lumendi, LLC 253 Post Rd. W., Westport CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FDF

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