Cleared Traditional

K803052 - NUFFIELD ANESTHESIA VENTILATOR SER. 400

K803052 is the FDA 510(k) clearance for NUFFIELD ANESTHESIA VENTILATOR SER. 400 by Penlon, Inc.. It is a Class 2 Anesthesiology device (product code BSZ) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K803052 · Penlon, Inc. · Anesthesiology device
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Jan 1981
Decision
36d
Days
Class 2
Risk

K803052 is an FDA 510(k) clearance for the NUFFIELD ANESTHESIA VENTILATOR SER. 400. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Penlon, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 7, 1981 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 Penlon, Inc. devices

Submission Details

510(k) Number K803052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1980
Decision Date January 07, 1981
Days to Decision 36 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 140d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 67
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K803052.
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K771989 · Draeger Medical, Inc. · Nov 1977
NARKOMED ANESTHESIA MACHINE
K770554 · Draeger Medical, Inc. · Mar 1977