Cleared Traditional

K914595 - PULSE RATE MONITOR

K914595 is an FDA 510(k) clearance for PULSE RATE MONITOR, manufactured by Fitness Quest, Inc.. The device is a Class 2 Anesthesiology device with product code DPZ cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K914595 · Fitness Quest, Inc. · Anesthesiology device
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Jan 1992
Decision
107d
Days
Class 2
Risk

K914595 is an FDA 510(k) clearance for the PULSE RATE MONITOR. Classified as Oximeter, Ear (product code DPZ), Class II - Special Controls.

Submitted by Fitness Quest, Inc. (Canton, US). The FDA issued a Cleared decision on January 31, 1992 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2710 - 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 Fitness Quest, Inc. devices

FDA 510(k) Submission Details - K914595

510(k) Number K914595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1991
Decision Date January 31, 1992
Days to Decision 107 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 140d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPZ Device Classification - Class 2, Special Controls

Product Code DPZ Oximeter, Ear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2710
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 - DPZ Oximeter, Ear

All 7
Devices cleared under the same product code (DPZ) and FDA review panel - the closest regulatory comparables to K914595.
DATEX-OHMEDA TRUSAT PULSE OXIMETER AND ACCESSORIES, MODEL 3500
K040831 · Datex-Ohmeda, Inc. · Sep 2004
DURA-Y OXYGEN TRANSDUCER, EAR CLIP
K944760 · Nellcor, Inc. · Oct 1994
MARQUETTE EAR PROBE SENSOR
K942752 · Marquette Electronics, Inc. · Sep 1994
PULSE OXIMETER
K862426 · Draeger Medical, Inc. · Sep 1986
OHMEDA BIOX 3700 PULSE OXIMETER
K850494 · Ohmeda Medical · Mar 1985
EAR OXIMETER
K810363 · Bio-Tek Instruments, Inc. · Feb 1981