Cleared Traditional

K910243 - MOBILE TREATMENT CART

K910243 is the FDA 510(k) clearance for MOBILE TREATMENT CART 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 85-day FDA review.

K910243 · Jedmed Instrument Co. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1991
Decision
85d
Days
Class 1
Risk

K910243 is an FDA 510(k) clearance for the MOBILE TREATMENT CART. 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 April 17, 1991 after a review of 85 days - a notably fast clearance cycle.

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: 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 K910243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1991
Decision Date April 17, 1991
Days to Decision 85 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 89d · This submission: 85d
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 K910243.
JEDMED SPECTRUM ENT CABINET
K953457 · Jedmed Instrument Co. · Aug 1995
PREMIER MIRROR WARMER
K945395 · Premier Dental Products Co. · Jan 1995
#491 POWER OTOLARYNGOLY CH/#498 PROCED CTR & ACCES
K910781 · Midmark Corp. · May 1991
SYSTEMA ENT CABINET
K896273 · Jedmed Instrument Co. · Jan 1990
JEDMED S CHAIR
K896298 · Jedmed Instrument Co. · Jan 1990
JEDMED MAXIM ENT CABINET
K881958 · Jedmed Instrument Co. · Jul 1988