Cleared Traditional

K844007 - PENLON PPV VAPORIZER

K844007 is an FDA 510(k) clearance for PENLON PPV VAPORIZER, manufactured by Penlon, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K844007

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.

CAD Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K844007.
OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER
K892057 · Ohmeda Medical · Apr 1989
VAPAMASTA 5
K884686 · Dentsply Intl. · Mar 1989
VAPLOK
K864605 · Bear Medical Systems, Inc. · Feb 1987
HALOTHANE VAPORIZER 950, ENFLURANE
K841157 · Siemens Elema AB · Jun 1984
MODULUS VERNI-TROL ANESTHETIC VAPORIZER
K821966 · Ohio Medical Products · Jul 1982
DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS
K821650 · Draeger Medical, Inc. · Jun 1982