Cleared Traditional

K871813 - VITALOG PMS-8 (MODIFICATION)

K871813 is an FDA 510(k) clearance for VITALOG PMS-8 (MODIFICATION), manufactured by Vitalog Corp.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K871813 · Vitalog Corp. · Anesthesiology device
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Nov 1987
Decision
199d
Days
Class 2
Risk

K871813 is an FDA 510(k) clearance for the VITALOG PMS-8 (MODIFICATION). Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Vitalog Corp. (Redwood, US). The FDA issued a Cleared decision on November 23, 1987 after a review of 199 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.

View all Vitalog Corp. devices

FDA 510(k) Submission Details - K871813

510(k) Number K871813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1987
Decision Date November 23, 1987
Days to Decision 199 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 140d · This submission: 199d
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 113
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K871813.
MODEL 9550/9500 RESPIRATION/HEART RATE MONITOR
K884637 · Aequitron Medical, Inc. · Jan 1989
MODEL 9216 RESPIRATION/HEART RATE MONITOR
K881266 · Aequitron Medical, Inc. · Jun 1988
HEALTHDYNE RATE METER
K874814 · Healthdyne, Inc. · Feb 1988
MODEL 500E INFANT MONITORING SYSTEM
K873791 · Ge Medical Systems Information Technologies · Nov 1987
MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR
K872954 · Aequitron Medical, Inc. · Oct 1987
MODEL NUMBER 8200 RESPIRATION/HEART RATE MONITOR
K871551 · Aequitron Medical, Inc. · Jun 1987