Cleared Traditional

K821505 - AIRWAY TEMPERATURE SENSOR

K821505 is the FDA 510(k) clearance for AIRWAY TEMPERATURE SENSOR by Mon-A-Therm, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K821505 · Mon-A-Therm, Inc. · General & Plastic Surgery device
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Dec 1982
Decision
203d
Days
Class 2
Risk

K821505 is an FDA 510(k) clearance for the AIRWAY TEMPERATURE SENSOR. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Mon-A-Therm, Inc. (Walker, US). The FDA issued a Cleared decision on December 9, 1982 after a review of 203 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Mon-A-Therm, Inc. devices

Submission Details

510(k) Number K821505 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1982
Decision Date December 09, 1982
Days to Decision 203 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d slower than avg
Panel avg: 115d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 893
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K821505.
DISPERSIVE ELECTRODE
K830545 · C.R. Bard, Inc. · Mar 1983
3M SCOTCHPLATE 51148 SMALL CONDUCTIVE
K823689 · 3M Company · Jan 1983
MODEL SSE4 ELECTROSURGICAL GENERATOR
K823924 · Valleylab, Inc. · Jan 1983
ELECTROSURGICAL UNIT
K823083 · Kelleher Corp. · Dec 1982
BIPOLAR COAGULATOR #9620/9621
K823184 · Concept, Inc. · Dec 1982
DISP. METAL & PLASTIC ELECTROSURG. DEV
K822355 · Valleylab, Inc. · Sep 1982