Cleared Traditional

K895946 - BIVONA CARDEN INTERMITTENT JETTING DEVICE

K895946 is an FDA 510(k) clearance for BIVONA CARDEN INTERMITTENT JETTING DEVICE, manufactured by Bivona Medical Technologies. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K895946 · Bivona Medical Technologies · Anesthesiology device
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Jan 1990
Decision
90d
Days
Class 2
Risk

K895946 is an FDA 510(k) clearance for the BIVONA CARDEN INTERMITTENT JETTING DEVICE. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Bivona Medical Technologies (Gary, US). The FDA issued a Cleared decision on January 9, 1990 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bivona Medical Technologies devices

FDA 510(k) Submission Details - K895946

510(k) Number K895946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1989
Decision Date January 09, 1990
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
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 49
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K895946.
AMBU MATIC AUTOMATIC RESUSCITATOR
K904920 · Ambu, Inc. · May 1991
POWERED VENTILATOR, LEVER I/II, BATTLEFIELD USE
K905697 · Impact Instrumentation, Inc. · Dec 1990
OHMEDA - LOGIC 07A TRANSPORT VENTILATOR
K901846 · Ohmeda Medical · Aug 1990
RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR
K892885 · Fisher & Paykel Electronics , Ltd. · Oct 1989
LSP AUTOMATIC VENTILATOR, MODEL 456
K870424 · Life Support Products, Inc. · Jan 1988
AUTOMATIC VENTILATOR AV2000
K874656 · Life Support Products, Inc. · Jan 1988