510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K870861Substantially Equivalent

Uni-Vent(tm) Impact Minute Volume Ventilator

ZOLL Medical Corporation, West Caldwell NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870861 is the FDA 510(k) clearance record for UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR, a class II device, cleared for Impact Instrumentation, Inc. on under FDA product code CBK (Ventilator, Continuous, Facility Use). FDA records list 149 510(k) clearances for ZOLL MEDICAL CORPORATION, from to . As of , FDA records show no recalls naming K870861.

Clearance record

Decision date
Received
(322 days to decision)
Product code
CBK Ventilator, Continuous, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Impact Instrumentation, Inc. P.O. Box 508, West Caldwell NJ
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