Cleared Traditional

K020329 - DEVILBISS PD1000

K020329 is an FDA 510(k) clearance for DEVILBISS PD1000, manufactured by Sunrise Medical Hhg, Inc.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K020329 · Sunrise Medical Hhg, Inc. · Anesthesiology device
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Jun 2002
Decision
139d
Days
Class 2
Risk

K020329 is an FDA 510(k) clearance for the DEVILBISS PD1000. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Sunrise Medical Hhg, Inc. (Somerset, US). The FDA issued a Cleared decision on June 19, 2002 after a review of 139 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5905 - 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 Sunrise Medical Hhg, Inc. devices

FDA 510(k) Submission Details - K020329

510(k) Number K020329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2002
Decision Date June 19, 2002
Days to Decision 139 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 140d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFB Device Classification - Class 2, Special Controls

Product Code NFB Conserver, Oxygen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5905
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 - NFB Conserver, Oxygen

All 39
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K020329.
EASY PULSE II OXYGEN CONSERVER
K032018 · Precision Medical, Inc. · Aug 2003
AIRLIFE DEMAND NASAL CANNULA
K023673 · Allegiance Healthcare Corp. · May 2003
CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511
K020475 · Chad Therapeutics, Inc. · Jul 2002
CHAD THERAPEUTICS OXYMATIC MODEL 401 AND OXYMATIC MODEL 411
K010389 · Chad Therapeutics, Inc. · Mar 2001
PM 1800 CONSERVING DEVICE
K001412 · Precision Medical, Inc. · Mar 2001
MODIFICATION TO CHAD THERAPEUTICS OXYMATIC MODEL 401
K003455 · Chad Therapeutics, Inc. · Dec 2000