510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K052554Substantially Equivalent

Modification to: Ivent 201 Portable Ventilator

Versamed Medical Systems, Inc., Pearl River NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K052554 is the FDA 510(k) clearance record for MODIFICATION TO: IVENT 201 PORTABLE VENTILATOR, a class II device, cleared for Versamed Medical Systems, Inc. on under FDA product code CBK (Ventilator, Continuous, Facility Use). FDA records list 8 510(k) clearances for Versamed Medical Systems, Inc., from to . As of , FDA records show no recalls naming K052554.

Clearance record

Decision date
Received
(7 days to decision)
Product code
CBK Ventilator, Continuous, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Versamed Medical Systems, Inc. 2 Blue Hill Plz., Pearl River NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CBK

Trailing 12 months
4 clearances under product code CBK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CBK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260