Cleared Traditional

K872954 - MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR

K872954 is an FDA 510(k) clearance for MODEL NUMBER 9216 RESPIRATION/HEART RAT..., manufactured by Aequitron Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K872954 · Aequitron Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1987
Decision
72d
Days
Class 2
Risk

K872954 is an FDA 510(k) clearance for the MODEL NUMBER 9216 RESPIRATION/HEART RATE MONITOR. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Aequitron Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 9, 1987 after a review of 72 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 Aequitron Medical, Inc. devices

FDA 510(k) Submission Details - K872954

510(k) Number K872954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1987
Decision Date October 09, 1987
Days to Decision 72 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
68d faster than avg
Panel avg: 140d · This submission: 72d
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 86
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K872954.
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 8200 RESPIRATION/HEART RATE MONITOR
K871551 · Aequitron Medical, Inc. · Jun 1987
MODEL 2000W OPTION H CONFIGURATION
K871302 · Edentec Corp. · Apr 1987
LIFEWATCH PLUS
K870661 · The Perkin-Elmer Corp. · Mar 1987