510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981668Substantially Equivalent

Smartvent 201 Portable Ventilator

Versamed, Ltd., Ra'Ananna 43373, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981668 is the FDA 510(k) clearance record for SMARTVENT 201 PORTABLE VENTILATOR, a class II device, cleared for Versamed , Ltd. on under FDA product code CBK (Ventilator, Continuous, Facility Use). FDA records list 3 510(k) clearances for Versamed , Ltd., from to . As of , FDA records show no recalls naming K981668.

Clearance record

Decision date
Received
(331 days to decision)
Product code
CBK Ventilator, Continuous, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Versamed , Ltd. 117 Ahuzah St., Ra'Ananna 43373, IL
510(k) summary
Summary
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