Cleared Traditional

BROWSER (EVENT SOFTWARE) MODEL # 4500E (K982550) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K982550 · Respironics, Inc. · Anesthesiology device
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Oct 1998
Decision
75d
Days
Class 2
Risk

K982550 is an FDA 510(k) clearance for the BROWSER (EVENT SOFTWARE) MODEL # 4500E. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on October 5, 1998 after a review of 75 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Respironics, Inc. devices

Submission Details

510(k) Number K982550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 22, 1998
Decision Date October 05, 1998
Days to Decision 75 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 140d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 34
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K982550.
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COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0
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MODEL 510 INFANT MONITOR
K943308 · Ge Medical Systems Information Technologies · Jul 1995
MODEL 511 INFANT MONITOR
K942170 · Ge Medical Systems Information Technologies · Jun 1995