Cleared Traditional

K113865 - PULTOL

K113865 is an FDA 510(k) clearance for PULTOL, manufactured by Sharp Corporation. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K113865 · Sharp Corporation · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
82d
Days
Class 2
Risk

K113865 is an FDA 510(k) clearance for the PULTOL. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Sharp Corporation (Richardson, US). The FDA issued a Cleared decision on March 21, 2012 after a review of 82 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 Sharp Corporation devices

FDA 510(k) Submission Details - K113865

510(k) Number K113865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2011
Decision Date March 21, 2012
Days to Decision 82 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
58d faster than avg
Panel avg: 140d · This submission: 82d
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 K113865.
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K121912 · Masimo Corporation · Jul 2012
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K120773 · Covidien, LLC · Jul 2012
PULSE OXIMETER
K112843 · Nonin Medical, Inc. · Apr 2012
MASIMO SET REUSABLE OXIMETRY SENSORS
K113596 · Masimo Corporation · Feb 2012
FINGERTIP PULSE OXIMETER
K112804 · Guangdong Biolight Meditech Co., Ltd. · Jan 2012
HANDHELD PULSE OXIMETER
K111494 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2012