510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K012271Substantially Equivalent

Acuteventilator

Impoex International, Ltd., Little River SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012271 is the FDA 510(k) clearance record for ACUTEVENTILATOR, a class II device, cleared for Impoex International, Ltd. on under FDA product code BTM (Ventilator, Emergency, Manual (Resuscitator)). FDA records list one 510(k) clearance for Impoex International, Ltd. As of , FDA records show no recalls naming K012271.

Clearance record

Decision date
Received
(442 days to decision)
Product code
BTM Ventilator, Emergency, Manual (Resuscitator)
Regulation
21 CFR 868.5915
Device class
Class II
Review panel
Anesthesiology
Applicant
Impoex International, Ltd. 500 Eagle Way #18, Little River SC
510(k) summary
Statement
Third party review
No

Clearances, product code BTM

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