Cleared Traditional

K921519 - OXICOM-2100

K921519 is the FDA 510(k) clearance for OXICOM-2100 by Waters Instruments, Inc.. It is a Class 2 Anesthesiology device (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

Submission Details

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.

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 249
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K921519.
OHMEDA HAND HELD OXIMETER
K931304 · Ohmeda Medical · Sep 1994
OXISAT
K934091 · Marquette Electronics, Inc. · Mar 1994
HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER
K923343 · Hewlett-Packard Co. · Feb 1993
MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
K923682 · Hewlett-Packard Co. · Sep 1992
CIBA CORNING MODEL 270 CO-OXIMETER
K913332 · Ciba Corning Diagnostics Corp. · Oct 1991
AP-860PA NIBP MODULE
K910629 · Nihon Kohden America, Inc. · May 1991