Cleared Traditional

K920988 - ATMOS MIRROR WARMER

K920988 is the FDA 510(k) clearance for ATMOS MIRROR WARMER by Jedmed Instrument Co.. It is a Class 1 Ear, Nose, Throat device (product code LRC) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K920988 · Jedmed Instrument Co. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1992
Decision
74d
Days
Class 1
Risk

K920988 is an FDA 510(k) clearance for the ATMOS MIRROR WARMER. Classified as Instrument, Ent Manual Surgical (product code LRC), Class I - General Controls.

Submitted by Jedmed Instrument Co. (St.Louis, US). The FDA issued a Cleared decision on May 15, 1992 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - 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: 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 Jedmed Instrument Co. devices

Submission Details

510(k) Number K920988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1992
Decision Date May 15, 1992
Days to Decision 74 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 89d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRC Instrument, Ent Manual Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
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 - LRC Instrument, Ent Manual Surgical

All 54
Devices cleared under the same product code (LRC) and FDA review panel - the closest regulatory comparables to K920988.
DISPOSABLE ENT PUNCH
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SYMBIOSIS ENT SURGICAL INSTRUMENTS
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HOUSE-BELLUCCI ALLIGATOR SCISSORS
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'EXMOOR' SINGLE USE SUCTION TUBE
K892504 · Exmoor Plastics , Ltd. · Jun 1989
FLEXIBLE ENDOSCOPE 91-8200(90) AND 91-82100(135)
K884631 · Xomed, Inc. · Mar 1989
'EXMOOR' MOFFAT-ROBINSON BONE PATE COLLECTOR
K864938 · Exmoor Plastics , Ltd. · Mar 1987