Cleared Traditional

K935309 - LUNG DIFFUSION

K935309 is an FDA 510(k) clearance for LUNG DIFFUSION, manufactured by Acetylene Gas Co.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K935309 · Acetylene Gas Co. · Anesthesiology device
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Sep 1994
Decision
329d
Days
Class 2
Risk

K935309 is an FDA 510(k) clearance for the LUNG DIFFUSION. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Acetylene Gas Co. (St. Louis, US). The FDA issued a Cleared decision on September 27, 1994 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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. Elevated predicate reliance profile. 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 Acetylene Gas Co. devices

FDA 510(k) Submission Details - K935309

510(k) Number K935309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1993
Decision Date September 27, 1994
Days to Decision 329 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 140d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZC Device Classification - Class 2, Special Controls

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 44
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K935309.
TRANSFLOW TEST
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K952542 · Ackrad Laboratories · Apr 1996
SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART
K915833 · Sensor Medics Corp. · Dec 1992
MODEL 2900 METABOLIC MEASUREMENT CART
K915686 · Sensor Medics Corp. · Dec 1992
MODIFIED STAR CALC
K895963 · Infrasonics Corp. · Mar 1990