Cleared Traditional

K874492 - LAWRENCE L4000 REFLECTANCE PULSE OXIMETER

K874492 is an FDA 510(k) clearance for LAWRENCE L4000 REFLECTANCE PULSE OXIMETER, manufactured by Lawrence Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K874492 · Lawrence Medical Systems, Inc. · Anesthesiology device
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Mar 1988
Decision
141d
Days
Class 2
Risk

K874492 is an FDA 510(k) clearance for the LAWRENCE L4000 REFLECTANCE PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Lawrence Medical Systems, Inc. (Cammarillo, US). The FDA issued a Cleared decision on March 22, 1988 after a review of 141 days - within the typical 510(k) review window.

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 Lawrence Medical Systems, Inc. devices

FDA 510(k) Submission Details - K874492

510(k) Number K874492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1987
Decision Date March 22, 1988
Days to Decision 141 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 140d · This submission: 141d
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 624
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K874492.
EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER
K881820 · Edentec Corp. · Jul 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
502-US PULSE OXIMETER
K875298 · Criticare Systems, Inc. · Mar 1988
DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER
K874442 · Critikon Company, LLC · Feb 1988
MODEL 8800 CARDIORESPIRATORY OXIMETER
K874947 · Nonin Medical, Inc. · Feb 1988