Cleared Traditional

K822328 - IL 301 TRANSCUTANEOUS OXYGEN MONITOR

K822328 is an FDA 510(k) clearance for IL 301 TRANSCUTANEOUS OXYGEN MONITOR, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Anesthesiology device with product code KLK cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K822328 · Instrumentation Laboratory CO · Anesthesiology device
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Sep 1982
Decision
35d
Days
Class 2
Risk

K822328 is an FDA 510(k) clearance for the IL 301 TRANSCUTANEOUS OXYGEN MONITOR. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on September 7, 1982 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2500 - 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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K822328

510(k) Number K822328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1982
Decision Date September 07, 1982
Days to Decision 35 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 140d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLK Device Classification - Class 2, Special Controls

Product Code KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2500
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 - KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia

All 32
Devices cleared under the same product code (KLK) and FDA review panel - the closest regulatory comparables to K822328.
OXY MONITOR 5-RANGE DUAL-THERMISTOR
K832652 · Litton Medical Electronics · Dec 1983
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AS 30/TCP MODULE
K831460 · Narco Scientific · Jul 1983
CRITIKON OXYGEN MONITOR, MODEL 8030
K821936 · Critikon Company, LLC · Aug 1982
NOVAMETRIX MODEL 807 TRANSCUT. MONITOR
K813350 · Novametrix Medical Systems, Inc. · Feb 1982
CRITIKON TRANSCUTANEOUS GAS MONITORS
K813347 · Critikon Company, LLC · Jan 1982