Cleared Traditional

K803052 - NUFFIELD ANESTHESIA VENTILATOR SER. 400

K803052 is an FDA 510(k) clearance for NUFFIELD ANESTHESIA VENTILATOR SER. 400, manufactured by Penlon, Inc.. The device is a Class 2 Anesthesiology device with 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.

FDA 510(k) Submission Details - K803052

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
Combination Product No
PCCP Authorized No
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.

BSZ Device Classification - Class 2, Special Controls

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 188
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K803052.
ANESTHESIA APPARATUS #FO 20S
K830160 · W.E. Leder Enterprises, Inc. · Mar 1983
ANESTHESIA APATATUS #D-25
K830161 · W.E. Leder Enterprises, Inc. · Mar 1983
NARKOMED 2A ANESTHESIA MACHINE
K822218 · Draeger Medical, Inc. · Sep 1982
MODEL 5460 + 5480 POP-OFF VALVES
K802591 · G. Dundas Co. · Nov 1980
COMPALOR-ORAL SURGERY MODEL
K801102 · Narco Mckesson Co. · Jun 1980
ANALGESIA UNITS, OXYGEN & NITRATE DEVICE
K800801 · Spica, Inc. · May 1980
K803052 · NUFFIELD ANESTHESIA VENTILATOR SER. 400
Download PDF Penlon, Inc.