510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013219Substantially Equivalent

Protoco2l Insufflator Model 6400

E-Z-EM, Inc, Westbury NY / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K013219 is the FDA 510(k) clearance record for PROTOCO2L INSUFFLATOR MODEL 6400, a class II device, cleared for E-Z-Em, Inc. on under FDA product code FCX (Insufflator, Automatic Carbon-Dioxide For Endoscope). FDA records list 56 510(k) clearances for E-Z-Em, Inc., from to . As of , FDA records show no recalls naming K013219.

Clearance record

Decision date
Received
(146 days to decision)
Product code
FCX Insufflator, Automatic Carbon-Dioxide For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
E-Z-Em, Inc. 717 Main St., Westbury NY
510(k) summary
Statement
Third party review
No

Clearances, product code FCX

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