Cleared Traditional

K994074 - TRI-BALL

K994074 is an FDA 510(k) clearance for TRI-BALL, manufactured by Leventon, S.A.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K994074 · Leventon, S.A. · Anesthesiology device
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Jun 2000
Decision
189d
Days
Class 2
Risk

K994074 is an FDA 510(k) clearance for the TRI-BALL. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Leventon, S.A. (Barcelona, ES). The FDA issued a Cleared decision on June 8, 2000 after a review of 189 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5690 - 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.

FDA 510(k) Submission Details - K994074

510(k) Number K994074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1999
Decision Date June 08, 2000
Days to Decision 189 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 140d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BWF Device Classification - Class 2, Special Controls

Product Code BWF Spirometer, Therapeutic (incentive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5690
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 - BWF Spirometer, Therapeutic (incentive)

All 79
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K994074.
AEROPEP
K012368 · Trudell Medical Intl. · Feb 2002
ACAPELLA
K002768 · Dhd Healthcare Corp. · Dec 2000
CLINIFLO INCENTIVE SPIROMETER
K003146 · Dhd Healthcare Corp. · Nov 2000
INCENTIVE SPIROMETER
K000314 · Engineered Medical Systems · Apr 2000
FROLOV'S RESPIRATION TRAINING DEVICE, FRTD-01
K992256 · Intercontinental New Technologies, Inc. · Jan 2000
ROADRUNNER, PEP THERAPY DEVICE
K991561 · Dhd Healthcare Corp. · Nov 1999