Cleared Traditional

K905697 - POWERED VENTILATOR

K905697 is an FDA 510(k) clearance for POWERED VENTILATOR, manufactured by Impact Instrumentation, Inc.. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K905697 · Impact Instrumentation, Inc. · Anesthesiology device
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Dec 1990
Decision
3d
Days
Class 2
Risk

K905697 is an FDA 510(k) clearance for the POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Impact Instrumentation, Inc. (West Caldwell, US). The FDA issued a Cleared decision on December 27, 1990 after a review of 3 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Impact Instrumentation, Inc. devices

FDA 510(k) Submission Details - K905697

510(k) Number K905697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1990
Decision Date December 27, 1990
Days to Decision 3 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d faster than avg
Panel avg: 140d · This submission: 3d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTL Ventilator, Emergency, Powered (resuscitator)

All 31
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K905697.
IMPACT MODEL 753
K931473 · Impact Instrumentation, Inc. · Dec 1994
OXYGEN POWERED RESUSCITATOR FOR CPR
K920910 · J. H. Emerson Co. · Jan 1993
AMBU MATIC AUTOMATIC RESUSCITATOR
K904920 · Ambu, Inc. · May 1991
OHMEDA - LOGIC 07A TRANSPORT VENTILATOR
K901846 · Ohmeda Medical · Aug 1990
BIVONA CARDEN INTERMITTENT JETTING DEVICE
K895946 · Bivona Medical Technologies · Jan 1990
IMPACT MODELS 701, 702 AND 703
K861272 · Impact Instrumentation, Inc. · May 1986