Cleared Traditional

K000831 - STAT-SHELL DISPOSABLE SP02 SENSOR

K000831 is an FDA 510(k) clearance for STAT-SHELL DISPOSABLE SP02 SENSOR, manufactured by Epic Medical Equipment Services, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 83-day FDA review.

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

FDA 510(k) Submission Details - K000831

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
57d faster than avg
Panel avg: 140d · This submission: 83d
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 511
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K000831.
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT
K002574 · Masimo Corp. · Sep 2000
MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500
K001930 · Nonin Medical, Inc. · Jul 2000
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
K001688 · Datex-Ohmeda, Inc. · Jun 2000
MODIFICATION TO ONYX, FINGER CLIP PULSE OXIMETER, MODEL 9500
K001085 · Nonin Medical, Inc. · May 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA
K000126 · Masimo Corp. · Apr 2000
MODIFICATION TO MARSPO2, MODEL 2001
K000794 · Novametrix Medical Systems, Inc. · Apr 2000