Cleared Traditional

K921519 - OXICOM-2100

K921519 is an FDA 510(k) clearance for OXICOM-2100, manufactured by Waters Instruments, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K921519 · Waters Instruments, Inc. · Anesthesiology device
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Oct 1992
Decision
206d
Days
Class 2
Risk

K921519 is an FDA 510(k) clearance for the OXICOM-2100. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Waters Instruments, Inc. (Rochester, US). The FDA issued a Cleared decision on October 23, 1992 after a review of 206 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 Waters Instruments, Inc. devices

FDA 510(k) Submission Details - K921519

510(k) Number K921519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1992
Decision Date October 23, 1992
Days to Decision 206 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 140d · This submission: 206d
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 533
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K921519.
OXYSHUTTLE II ,MODIFICATION
K925542 · Sensor Medics Corp. · Feb 1993
HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER
K923343 · Hewlett-Packard Co. · Feb 1993
BIOCHEM MODEL 3301 NEWOX1 OXIMETER
K920082 · Biochem International, Inc. · Jan 1993
MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
K923682 · Hewlett-Packard Co. · Sep 1992
NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX
K920379 · Novametrix Medical Systems, Inc. · Jul 1992
SENSORMEDICS OXYSHUTTLE II(TM)
K913790 · Sensor Medics Corp. · Feb 1992