Cleared Traditional

K842048 - SUN-ONE

K842048 is an FDA 510(k) clearance for SUN-ONE, manufactured by Ensun Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K842048 · Ensun Medical Products, Inc. · Anesthesiology device
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Nov 1984
Decision
163d
Days
Class 2
Risk

K842048 is an FDA 510(k) clearance for the SUN-ONE. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Ensun Medical Products, Inc. (Houston, US). The FDA issued a Cleared decision on November 1, 1984 after a review of 163 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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 - K842048

510(k) Number K842048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1984
Decision Date November 01, 1984
Days to Decision 163 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 140d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZQ Device Classification - Class 2, Special Controls

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - BZQ Monitor, Breathing Frequency

All 128
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K842048.
EDENTEC MODEL 2000W APNEA MONITOR
K844327 · Edentec Corp. · Jul 1985
COROMETRICS 500 INFANT MONITOR
K850504 · Ge Medical Systems Information Technologies · Jun 1985
RESPIRATION & HEART RATE MONITOR 530
K843681 · Tri-Med, Inc. · Dec 1984
INFANT MONITOR 16900
K843546 · Healthdyne, Inc. · Oct 1984
EEG & RESPIRATION MODULES POLYGRAPH
K823563 · Nihon Kohden America, Inc. · Jan 1983
TRIMED 510 APNEA MONITOR
K822819 · Tri-Med, Inc. · Nov 1982
K842048 · SUN-ONE
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