Cleared Traditional

K072621 - ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND...

K072621 is an FDA 510(k) clearance for ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND..., manufactured by Cincinnati Sub-Zero Products, Inc.. The device is a Class 2 Anesthesiology device with product code BZT cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K072621 · Cincinnati Sub-Zero Products, Inc. · Anesthesiology device
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Dec 2007
Decision
87d
Days
Class 2
Risk

K072621 is an FDA 510(k) clearance for the ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATU.... Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Cincinnati Sub-Zero Products, Inc. (Sharonville, US). The FDA issued a Cleared decision on December 13, 2007 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1920 - 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 Cincinnati Sub-Zero Products, Inc. devices

FDA 510(k) Submission Details - K072621

510(k) Number K072621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2007
Decision Date December 13, 2007
Days to Decision 87 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
53d faster than avg
Panel avg: 140d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZT Device Classification - Class 2, Special Controls

Product Code BZT Stethoscope, Esophageal, With Electrical Conductors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1920
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 - BZT Stethoscope, Esophageal, With Electrical Conductors

All 22
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K072621.
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