Cleared Traditional

K844008 - PENLON AM1000 ANAESTHESIA MACHINE

K844008 is an FDA 510(k) clearance for PENLON AM1000 ANAESTHESIA MACHINE, 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 151-day FDA review.

K844008 · Penlon, Inc. · Anesthesiology device
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Mar 1985
Decision
151d
Days
Class 2
Risk

K844008 is an FDA 510(k) clearance for the PENLON AM1000 ANAESTHESIA MACHINE. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Penlon, Inc. (Abingdon Ox, GB). The FDA issued a Cleared decision on March 12, 1985 after a review of 151 days - an extended review 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: 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 Penlon, Inc. devices

FDA 510(k) Submission Details - K844008

510(k) Number K844008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1984
Decision Date March 12, 1985
Days to Decision 151 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 140d · This submission: 151d
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 143
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K844008.
OHMEDA PAC PORTABLE ANESTHESIA SYSTEM
K850648 · Ohmeda Medical · Jul 1985
OHMEDA MDM ELECTRONIC-GAS MACHINE FOR ANALGESIA
K844849 · Ohmeda Medical · May 1985
BOOM ARM
K851621 · Draeger Medical, Inc. · May 1985
FOREGGER DOME VALVES
K844421 · Puritan Bennett Corp. · Jan 1985
OHMEDA ANESTHESIA RECORD KEEPER
K844012 · Ohmeda Medical · Oct 1984
OHIO UNITROL II ANESTHESIA GAS MACHINE
K840356 · Ohio Medical Products · Apr 1984