510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K052751Substantially Equivalent

Ventlink System

Mediserve Information Systems, Inc., Tempe AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052751 is the FDA 510(k) clearance record for VENTLINK SYSTEM, a class II device, cleared for Mediserve Information Systems, Inc. on under FDA product code MOD (Accessory To Continuous Ventilator (Respirator)). FDA records list one 510(k) clearance for Mediserve Information Systems, Inc. As of , FDA records show no recalls naming K052751.

Clearance record

Decision date
Received
(84 days to decision)
Product code
MOD Accessory To Continuous Ventilator (Respirator)
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Mediserve Information Systems, Inc. 3225 S. Hardy Dr., Suite 101, Tempe AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MOD

Trailing 12 months
3 clearances under product code MOD in the twelve months to October 2026, August 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MOD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20262
September 20260
October 20260