Cleared Traditional

K864730 - INVIVO PULSE OXIMETER, MODEL 4500

K864730 is an FDA 510(k) clearance for INVIVO PULSE OXIMETER, manufactured by Invivo Research Labs, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K864730 · Invivo Research Labs, Inc. · Anesthesiology device
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May 1987
Decision
153d
Days
Class 2
Risk

K864730 is an FDA 510(k) clearance for the INVIVO PULSE OXIMETER, MODEL 4500. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Invivo Research Labs, Inc. (Tulsa, US). The FDA issued a Cleared decision on May 6, 1987 after a review of 153 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 Invivo Research Labs, Inc. devices

FDA 510(k) Submission Details - K864730

510(k) Number K864730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1986
Decision Date May 06, 1987
Days to Decision 153 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 140d · This submission: 153d
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 625
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K864730.
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OXIMETER
K871353 · Radiometer America, Inc. · Jun 1987
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K870621 · Datex Division Instrumentarium Corp. · Mar 1987
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K864279 · Spacelabs, Inc. · Mar 1987
502 OXYGEN SATURATION MONITOR
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