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)
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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.

View all Tenacore Holdings, Inc. devices

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
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 478
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K053420.
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
RAINBOW ADHESIVE CO-OXIMETRY SENSORS
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
MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03
K062268 · Philips Medical Systems North America Co. · Oct 2006