Cleared Traditional

K984570 - MINOLTA PULSOX-3/MINOLTA PULSOX-3I

K984570 is an FDA 510(k) clearance for MINOLTA PULSOX-3/MINOLTA PULSOX-3I, manufactured by In-X Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 616-day FDA review.

K984570 · In-X Corp. · Anesthesiology device
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Aug 2000
Decision
616d
Days
Class 2
Risk

K984570 is an FDA 510(k) clearance for the MINOLTA PULSOX-3/MINOLTA PULSOX-3I. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by In-X Corp. (Lakewood, US). The FDA issued a Cleared decision on August 30, 2000 after a review of 616 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all In-X Corp. devices

FDA 510(k) Submission Details - K984570

510(k) Number K984570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1998
Decision Date August 30, 2000
Days to Decision 616 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
476d slower than avg
Panel avg: 140d · This submission: 616d
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 552
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K984570.
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K002682 · Masimo Corp. · Sep 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K002477 · Masimo Corp. · Sep 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT
K002574 · Masimo Corp. · Sep 2000
MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500
K001930 · Nonin Medical, Inc. · Jul 2000
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
K001688 · Datex-Ohmeda, Inc. · Jun 2000
MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
K001085 · Nonin Medical, Inc. · May 2000