Cleared Abbreviated

Accu O2 Oxygen Analyzer (K173807) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K173807 · Precision Medical, Inc. · Anesthesiology device
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May 2018
Decision
138d
Days
Class 2
Risk

K173807 is an FDA 510(k) clearance for the Accu O2 Oxygen Analyzer. Classified as Analyzer, Gas, Oxygen, Gaseous-phase (product code CCL), Class II - Special Controls.

Submitted by Precision Medical, Inc. (Northampton, US). The FDA issued a Cleared decision on May 2, 2018 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1720 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Precision Medical, Inc. devices

Submission Details

510(k) Number K173807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2017
Decision Date May 02, 2018
Days to Decision 138 days
Submission Type Abbreviated
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
2d faster than avg
Panel avg: 140d · This submission: 138d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 13
Devices cleared under the same product code (CCL) and FDA review panel - the closest regulatory comparables to K173807.
Maxtec MaxO2 ME+p
K221734 · Maxtec, LLC · Apr 2023
Percent Oxygen Sensors
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DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC
K051092 · Ge Healthcare · May 2005
SIEMENS FIO2 SENSOR
K991884 · Siemens Medical Solutions USA, Inc. · Nov 1999
HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02
K982619 · Hewlett-Packard Co. · Aug 1998