Cleared Traditional

K882664 - MRL OXIMETER

K882664 is an FDA 510(k) clearance for MRL OXIMETER, manufactured by Medical Research Laboratories, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K882664 · Medical Research Laboratories, Inc. · Anesthesiology device
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Sep 1988
Decision
81d
Days
Class 2
Risk

K882664 is an FDA 510(k) clearance for the MRL OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Medical Research Laboratories, Inc. (Niles, US). The FDA issued a Cleared decision on September 16, 1988 after a review of 81 days - a notably fast clearance 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: 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 Medical Research Laboratories, Inc. devices

FDA 510(k) Submission Details - K882664

510(k) Number K882664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1988
Decision Date September 16, 1988
Days to Decision 81 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 140d · This submission: 81d
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 477
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K882664.
BM-103 BATTERY MODULE
K883877 · Datex Division Instrumentarium Corp. · Oct 1988
KONTRON PULSE OXIMETER 7840
K873624 · Kontron Instruments, Inc. · Oct 1988
HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER
K883297 · Hewlett-Packard Co. · Oct 1988
HORIZON 2000 PULSE OXIMETRY AND MODULE
K882273 · Mennen Medical, Inc. · Aug 1988
SATLITE+/PB251+ PULSE OXIMETER
K881883 · Datex Division Instrumentarium Corp. · Jul 1988
HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI.
K881136 · Hewlett-Packard Co. · May 1988