Cleared Traditional

STAT-SHELL DISPOSABLE SP02 SENSOR (K000831) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K000831 · Epic Medical Equipment Services, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
83d
Days
Class 2
Risk

K000831 is an FDA 510(k) clearance for the STAT-SHELL DISPOSABLE SP02 SENSOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Epic Medical Equipment Services, Inc. (Plano, US). The FDA issued a Cleared decision on June 5, 2000 after a review of 83 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Epic Medical Equipment Services, Inc. devices

Submission Details

510(k) Number K000831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2000
Decision Date June 05, 2000
Days to Decision 83 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
56d faster than avg
Panel avg: 139d · This submission: 83d
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 159
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K000831.
SIEMENS MICRO2+ WITH VAI SOFTWARE
K030640 · Siemens Medical Solutions USA, Inc. · Jun 2003
SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER
K022766 · Siemens Medical Solutions USA, Inc. · Sep 2002
INFINITY MICRO2+
K012770 · Siemens Medical Solutions USA, Inc. · Jul 2002
NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
K992455 · Nihon Kohden America, Inc. · Jan 2000
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K991661 · Siemens Medical Solutions USA, Inc. · May 1999
NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES
K974292 · Nihon Kohden America, Inc. · Jun 1998