510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K200419Substantially Equivalent

Kalera Vacuum Aspiration Catheter (K-VAC)

Kalera Medical, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200419 is the FDA 510(k) clearance record for Kalera Vacuum Aspiration Catheter (K-VAC), a class II device, cleared for Kalera Medical, Inc. on under FDA product code FED (Endoscopic Access Overtube, Gastroenterology-Urology). FDA's definition for product code FED reads: "To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation". FDA records list one 510(k) clearance for Kalera Medical, Inc. As of , FDA records show no recalls naming K200419.

Clearance record

Decision date
Received
(92 days to decision)
Product code
FED Endoscopic Access Overtube, Gastroenterology-Urology
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Kalera Medical, Inc. 13240 Evening Creek Dr. S., Suite 304, San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FED

Trailing 12 months
5 clearances under product code FED in the twelve months to October 2026, September 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code FED, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20262
May 20260
June 20260
July 20260
August 20260
September 20263
October 20260