510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K905697Substantially Equivalent

Powered Ventilator, Lever i/ii, Battlefield Use

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

K905697 is the FDA 510(k) clearance record for POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE, a class II device, cleared for Impact Instrumentation, Inc. on under FDA product code BTL (Ventilator, Emergency, Powered (Resuscitator)). FDA records list 149 510(k) clearances for ZOLL MEDICAL CORPORATION, from to . As of , FDA records show no recalls naming K905697.

Clearance record

Decision date
Received
(3 days to decision)
Product code
BTL Ventilator, Emergency, Powered (Resuscitator)
Regulation
21 CFR 868.5925
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 BTL

Trailing 12 months

FDA records hold no clearances under product code BTL in the trailing twelve months.

FDA records show no clearances under product code BTL in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BTL, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260