Cleared Traditional

K102442 - E.S.O. (ELECTRO SENSOR OXI)

K102442 is the FDA 510(k) clearance for E.S.O. (ELECTRO SENSOR OXI) by Ld Technology, LLC. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K102442 · Ld Technology, LLC · Anesthesiology device
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Sep 2010
Decision
15d
Days
Class 2
Risk

K102442 is an FDA 510(k) clearance for the E.S.O. (ELECTRO SENSOR OXI). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Ld Technology, LLC (Miami, US). The FDA issued a Cleared decision on September 10, 2010 after a review of 15 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 Ld Technology, LLC devices

Submission Details

510(k) Number K102442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2010
Decision Date September 10, 2010
Days to Decision 15 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 140d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 369
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K102442.
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MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER
K100428 · Masimo Corporation · Jul 2010
MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7
K100403 · Masimo Corporation · Jun 2010
SINGLE-PATIENT USE DISPOSABLE SENSOR SERIES
K093853 · Nonin Medical, Inc. · Jun 2010