Cleared Traditional

K982283 - WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYGEN FLOW GENERATOR - FIXED MODEL WF 8530 WH

K982283 is an FDA 510(k) clearance for WHISPERFLOW OXYGEN FLOW GENERATOR - ADJ..., manufactured by Caradyne, Ltd.. The device is a Class 2 Anesthesiology device with product code BYE cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K982283 · Caradyne, Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
252d
Days
Class 2
Risk

K982283 is an FDA 510(k) clearance for the WHISPERFLOW OXYGEN FLOW GENERATOR - ADJUSTABLE MODEL WF 8500 WHISPERFLOW OXYG.... Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Caradyne, Ltd. (Mccordsville, US). The FDA issued a Cleared decision on March 9, 1999 after a review of 252 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5965 - 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 - K982283

510(k) Number K982283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1998
Decision Date March 09, 1999
Days to Decision 252 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 140d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYE Device Classification - Class 2, Special Controls

Product Code BYE Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5965
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 - BYE Attachment, Breathing, Positive End Expiratory Pressure

All 69
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K982283.
KOO AMERICAS VALVE PEEP, MODEL KM-809
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BOUSSIGNAC C.P.A.P. DEVICE
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CPAP SYSTEM, MODEL 102001
K001318 · Sims Portex, Inc. · Jul 2000
EMS PEEP VALVES- ADJUSTABLE
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0-20 CM H20 PEEP VALVE
K981415 · Cheen Houng Ent. Co. , Ltd. · Jul 1998
REUSABLE, ADJUSTABLE, MAGNETIC PEEP VALVE BE 142
K963347 · Instrumentation Industries, Inc. · Mar 1997