Cleared Traditional

K812976 - ARGYLE ACC-U-THERM W/TEMPERATURE PROBE

K812976 is the FDA 510(k) clearance for ARGYLE ACC-U-THERM W/TEMPERATURE PROBE by Sherwood Medical Co.. It is a Class 2 Anesthesiology device (product code BZT) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K812976 · Sherwood Medical Co. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1981
Decision
46d
Days
Class 2
Risk

K812976 is an FDA 510(k) clearance for the ARGYLE ACC-U-THERM W/TEMPERATURE PROBE. Classified as Stethoscope, Esophageal, With Electrical Conductors (product code BZT), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on December 8, 1981 after a review of 46 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K812976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1981
Decision Date December 08, 1981
Days to Decision 46 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 140d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (BZT) and FDA review panel - the closest regulatory comparables to K812976.
SHERIDAN YSI/SONATEMP
K841098 · Sheridan Catheter Corp. · Apr 1984
MODEL 40-80-2 DISPOS. ESOPHAGEAL STETHO
K823743 · Y · Jan 1983
CRITIKON #817 ESOPHAGEAL MULTI-PROBE
K821890 · Critikon Company, LLC · Aug 1982
HI-LO TEMP ESOPHAGEAL STETHOSCOPE
K811862 · Mallinckrodt Critical Care · Jul 1981