Cleared Traditional

K855021 - LARYNGEAL MIRROR PRE-WARMER

K855021 is the FDA 510(k) clearance for LARYNGEAL MIRROR PRE-WARMER by Jedmed Instrument Co.. It is a Class 1 Ear, Nose, Throat device (product code ETF) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K855021 · Jedmed Instrument Co. · Ear, Nose, Throat device
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Mar 1986
Decision
94d
Days
Class 1
Risk

K855021 is an FDA 510(k) clearance for the LARYNGEAL MIRROR PRE-WARMER. Classified as Unit, Examining/treatment, Ent (product code ETF), Class I - General Controls.

Submitted by Jedmed Instrument Co. (St. Louis, US). The FDA issued a Cleared decision on March 20, 1986 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.5300 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Jedmed Instrument Co. devices

Submission Details

510(k) Number K855021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1985
Decision Date March 20, 1986
Days to Decision 94 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 89d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ETF Unit, Examining/treatment, Ent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.5300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ETF Unit, Examining/treatment, Ent

All 23
Devices cleared under the same product code (ETF) and FDA review panel - the closest regulatory comparables to K855021.
JEDMED S CHAIR
K896298 · Jedmed Instrument Co. · Jan 1990
JEDMED MAXIM ENT CABINET
K881958 · Jedmed Instrument Co. · Jul 1988
MICROMEDICS STERILE, DISPOSABLE ENT EXAM KIT
K860940 · Micromedics, Inc. · May 1986
INSTRUMENT CABINET
K833882 · Jedmed Instrument Co. · Jan 1984
ENT TREATMENT UNITS
K822252 · Kelleher Corp. · Nov 1982
MULTIPLE, ENT CABINET #448
K822531 · Midmark Corp. · Sep 1982