Cleared Traditional

K924285 - MODEL 3500 MR-COMPATIBLE PULSE OXIMETER

K924285 is an FDA 510(k) clearance for MODEL 3500 MR-COMPATIBLE PULSE OXIMETER, manufactured by Magnetic Resonance Equipment Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K924285 · Magnetic Resonance Equipment Corp. · Anesthesiology device
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May 1993
Decision
259d
Days
Class 2
Risk

K924285 is an FDA 510(k) clearance for the MODEL 3500 MR-COMPATIBLE PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Magnetic Resonance Equipment Corp. (Bay Shore, US). The FDA issued a Cleared decision on May 11, 1993 after a review of 259 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 Magnetic Resonance Equipment Corp. devices

FDA 510(k) Submission Details - K924285

510(k) Number K924285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1992
Decision Date May 11, 1993
Days to Decision 259 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
119d slower than avg
Panel avg: 140d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 575
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K924285.
NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS
K940463 · Nonin Medical, Inc. · Mar 1994
NOVAMETRIX MODEL 510
K924626 · Novametrix Medical Systems, Inc. · Dec 1993
NELLCOR PORTABLE PULSE OXIMETER MODEL N-20
K915699 · Nellcor, Inc. · May 1993
9293/1 INTERFACE MODULE
K923418 · S & W Medico Teknik · Feb 1993
OXYSHUTTLE II ,MODIFICATION
K925542 · Sensor Medics Corp. · Feb 1993
HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER
K923343 · Hewlett-Packard Co. · Feb 1993