Cleared Traditional

K971084 - MODEL 02 OXYGEN ANALYZER

K971084 is an FDA 510(k) clearance for MODEL 02 OXYGEN ANALYZER, manufactured by Oxigraf, Inc.. The device is a Class 2 Anesthesiology device with product code CCL cleared through the Traditional 510(k) pathway after a 483-day FDA review.

K971084 · Oxigraf, Inc. · Anesthesiology device
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Jul 1998
Decision
483d
Days
Class 2
Risk

K971084 is an FDA 510(k) clearance for the MODEL 02 OXYGEN ANALYZER. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Oxigraf, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 21, 1998 after a review of 483 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Oxigraf, Inc. devices

FDA 510(k) Submission Details - K971084

510(k) Number K971084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1997
Decision Date July 21, 1998
Days to Decision 483 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
343d slower than avg
Panel avg: 140d · This submission: 483d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCL Device Classification - Class 2, Special Controls

Product Code CCL Analyzer, Gas, Oxygen, Gaseous-phase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1720
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 - CCL Analyzer, Gas, Oxygen, Gaseous-phase

All 53
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K971084.
SIEMENS FIO2 SENSOR
K991884 · Siemens Medical Solutions USA, Inc. · Nov 1999
INVACARE CHECK O2 PLUS CONCENTRATOR ANALYZER (CHECK O2 PLUS)
K984295 · Invacare Corp. · Jul 1999
HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02
K982619 · Hewlett-Packard Co. · Aug 1998
VACU*MED GOLD EDITION OXYGEN GAS ANALYZER
K973545 · Vacumed, Div. of Vacumetrics, Inc. · May 1998
CERAMATEC MAXCELL AND CAG GALVANIC OXYGEN SENSORS
K972992 · Ceramatec, Inc. · Mar 1998
HANDI OXYGEN ANALYZER
K973282 · Ceramatec, Inc. · Mar 1998