Cleared Traditional

K062724 - ACCUPULSE PULSE OXIMETER

K062724 is an FDA 510(k) clearance for ACCUPULSE PULSE OXIMETER, manufactured by Eagle Medical Equipment Co.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K062724 · Eagle Medical Equipment Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
241d
Days
Class 2
Risk

K062724 is an FDA 510(k) clearance for the ACCUPULSE PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Eagle Medical Equipment Co. (Mesa, US). The FDA issued a Cleared decision on May 11, 2007 after a review of 241 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 Eagle Medical Equipment Co. devices

FDA 510(k) Submission Details - K062724

510(k) Number K062724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2006
Decision Date May 11, 2007
Days to Decision 241 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
101d slower than avg
Panel avg: 140d · This submission: 241d
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 478
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K062724.
DIGITAL PULSE OXIMETER, MODEL 7500
K071285 · Nonin Medical, Inc. · Jul 2007
MODIFICATION TO: RAINBOW ADHESIVE CO-OXIMETRY SENSORS
K071024 · Masimo Corporation · Jun 2007
DURAMAX REUSABLE OXIMETRY SENSOR
K070408 · Nellcor Puritan Bennett, Inc. · May 2007
LIFESENSE, MODEL LS1-9R
K063752 · Nonin Medical, Inc. · May 2007
PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A
K063783 · Philips Medical Systems, Inc. · Apr 2007
CADWELL EASYNET OXIMETER MODULE
K061706 · Cadwell Laboratories, Inc. · Mar 2007