Cleared Traditional

K844007 - PENLON PPV VAPORIZER

K844007 is the FDA 510(k) clearance for PENLON PPV VAPORIZER by Penlon, Inc.. It is a Class 2 Anesthesiology device (product code CAD) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K844007 · Penlon, Inc. · Anesthesiology device
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Mar 1985
Decision
151d
Days
Class 2
Risk

K844007 is an FDA 510(k) clearance for the PENLON PPV VAPORIZER. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Penlon, Inc. (Riverside, US). 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 868.5880 - 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

Submission Details

510(k) Number K844007 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.

Device Classification

Product Code CAD Vaporizer, Anesthesia, Non-heated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5880
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 - CAD Vaporizer, Anesthesia, Non-heated

All 15
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K844007.
OHMEDA TEC 6 CONTINUOUS FLOW VAPORIZER
K913593 · Ohmeda Medical · Oct 1992
OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER
K892057 · Ohmeda Medical · Apr 1989
VAPAMASTA 5
K884686 · Dentsply Intl. · Mar 1989
DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS
K821650 · Draeger Medical, Inc. · Jun 1982
VAPOR 19
K771899 · Draeger Medical, Inc. · Oct 1977