Cleared Traditional

K892639 - THE ORIGINAL PULSE-PAK

K892639 is an FDA 510(k) clearance for THE ORIGINAL PULSE-PAK, manufactured by Jones Sales Co.. The device is a Class 2 Anesthesiology device with product code NFB cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K892639 · Jones Sales Co. · Anesthesiology device
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Oct 1989
Decision
176d
Days
Class 2
Risk

K892639 is an FDA 510(k) clearance for the THE ORIGINAL PULSE-PAK. Classified as Conserver, Oxygen (product code NFB), Class II - Special Controls.

Submitted by Jones Sales Co. (Canal Winchester, US). The FDA issued a Cleared decision on October 5, 1989 after a review of 176 days - an extended review cycle.

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.

FDA 510(k) Submission Details - K892639

510(k) Number K892639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1989
Decision Date October 05, 1989
Days to Decision 176 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 140d · This submission: 176d
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 64
Devices cleared under the same product code (NFB) and FDA review panel - the closest regulatory comparables to K892639.
MODEL IPD OXYGEN CONSERVING DEVICE
K953852 · Invacare Corp. · Nov 1995
MEDISONIC OXYGEN FLOW CONTROLLER
K923660 · Medisonic U.S.A., Inc. · Jan 1993
HALA'TUS 1 OXYGENATOR
K903504 · The Henry G. Dietz Co., Inc. · Jan 1991
MODIFIED DEMAND NASAL OXYGEN CANNULA
K892407 · Salter Labs · Jul 1989
DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE)
K890141 · Devilbiss Health Care, Inc. · Apr 1989
DEMAND NASAL OXYGEN CANNULA MODELS 4008/4108/4208
K890298 · Salter Labs · Feb 1989
K892639 · THE ORIGINAL PULSE-PAK
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