Cleared Traditional

K820353 - MONITRON MODEL JL-7

K820353 is the FDA 510(k) clearance for MONITRON MODEL JL-7 by Florida Medical Equipment Repair, Inc.. It is a Class 2 Anesthesiology device (product code CAP) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K820353 · Florida Medical Equipment Repair, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1982
Decision
32d
Days
Class 2
Risk

K820353 is an FDA 510(k) clearance for the MONITRON MODEL JL-7. Classified as Monitor, Airway Pressure (includes Gauge And/or Alarm) (product code CAP), Class II - Special Controls.

Submitted by Florida Medical Equipment Repair, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1982 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2600 - 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 Florida Medical Equipment Repair, Inc. devices

Submission Details

510(k) Number K820353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1982
Decision Date March 12, 1982
Days to Decision 32 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 140d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2600
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 - CAP Monitor, Airway Pressure (includes Gauge And/or Alarm)

All 14
Devices cleared under the same product code (CAP) and FDA review panel - the closest regulatory comparables to K820353.
MODIFIED BAROMED BREATHING PRESSURE MONITOR
K861720 · Draeger Medical, Inc. · May 1986
DRAGER BAROMED
K840279 · Draeger Medical, Inc. · Mar 1984
SINGLE USE NON-CONDUCTIVE CIRC. DISCON
K821667 · Vital Signs, Inc. · Jun 1982
BIRD MEAN AIRWAY PRESSURE MONITOR
K812140 · 3M Company · Aug 1981
TRAVENOL ULTRASONIC NEBULIZER CUPS
K802054 · Travenol Laboratories, S.A. · Dec 1980
DRAGER PRESSURE MONITOR, SELF-DIAGNOSTIC
K802090 · Draeger Medical, Inc. · Sep 1980