Cleared Traditional

K051736 - FOX PULSE OXIMETER

K051736 is an FDA 510(k) clearance for FOX PULSE OXIMETER, manufactured by Shunsuke Nakanishi. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K051736 · Shunsuke Nakanishi · Anesthesiology device
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Dec 2005
Decision
157d
Days
Class 2
Risk

K051736 is an FDA 510(k) clearance for the FOX PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shunsuke Nakanishi (San Marino, US). The FDA issued a Cleared decision on December 2, 2005 after a review of 157 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 Shunsuke Nakanishi devices

FDA 510(k) Submission Details - K051736

510(k) Number K051736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2005
Decision Date December 02, 2005
Days to Decision 157 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
17d slower than avg
Panel avg: 140d · This submission: 157d
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 K051736.
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100
K052669 · Nonin Medical, Inc. · Dec 2005
ADULT CEREBRAL OXIMETER, MODEL 2040
K051257 · Cas Medical Systems, Inc. · Dec 2005
MASIMO SET RAD-8 PULSE OXIMETER
K053269 · Masimo Corporation · Dec 2005
PHILIPS DISPOSABLE SPO2 SENSORS MII32A AND M1133A.
K052377 · Philips Medizin Systeme Boeblingen GmbH · Nov 2005
NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P
K052186 · Nellcor Puritan Bennett, Inc. · Nov 2005
WRISTOX MODEL 3100 PULSE OXIMETER
K052829 · Nonin Medical, Inc. · Nov 2005