Cleared Traditional

K100077 - NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-F...

K100077 is an FDA 510(k) clearance for NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-F..., manufactured by Solaris Medical Technology, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K100077 · Solaris Medical Technology, Inc. · Anesthesiology device
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Oct 2010
Decision
268d
Days
Class 2
Risk

K100077 is an FDA 510(k) clearance for the NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Solaris Medical Technology, Inc. (South San Francisco, US). The FDA issued a Cleared decision on October 7, 2010 after a review of 268 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 Solaris Medical Technology, Inc. devices

FDA 510(k) Submission Details - K100077

510(k) Number K100077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2010
Decision Date October 07, 2010
Days to Decision 268 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d slower than avg
Panel avg: 140d · This submission: 268d
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 478
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K100077.
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MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1
K101031 · Masimo Corporation · Nov 2010
MASIMO LNCS/M-LNCS OXIMETRY SENSORS
K101896 · Masimo Corporation · Oct 2010
TRUSIGNAL SPO2 FINGERTIP SENSOR
K101871 · GE Healthcare Finland Oy · Oct 2010
HANDHELD PULSE OXIMETER MODEL M800
K101694 · Guangdong Biolight Meditech Co., Ltd. · Sep 2010
INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216, INTELLIVUE PATIENT MONITORS MP5, MP2, X2 MODEL
K101600 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Aug 2010