Cleared Traditional

K053420 - TENACORE SP02 SENSORS

K053420 is an FDA 510(k) clearance for TENACORE SP02 SENSORS, manufactured by Tenacore Holdings, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 342-day FDA review.

K053420 · Tenacore Holdings, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
342d
Days
Class 2
Risk

K053420 is an FDA 510(k) clearance for the TENACORE SP02 SENSORS. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Tenacore Holdings, Inc. (Santa Ana, US). The FDA issued a Cleared decision on November 15, 2006 after a review of 342 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K053420

510(k) Number K053420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2005
Decision Date November 15, 2006
Days to Decision 342 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 140d · This submission: 342d
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 686
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K053420.
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K063140 · Masimo Corporation · Dec 2006
PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T
K062605 · Philips Medical Systems · Nov 2006
PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL
K062455 · Philips Medical Systems · Nov 2006
TELEVISIT
K062338 · PHD Medical · Oct 2006