Cleared Traditional

K813350 - NOVAMETRIX MODEL 807 TRANSCUT. MONITOR

K813350 is an FDA 510(k) clearance for NOVAMETRIX MODEL 807 TRANSCUT. MONITOR, manufactured by Novametrix Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code KLK cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K813350 · Novametrix Medical Systems, Inc. · Anesthesiology device
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Feb 1982
Decision
77d
Days
Class 2
Risk

K813350 is an FDA 510(k) clearance for the NOVAMETRIX MODEL 807 TRANSCUT. MONITOR. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Novametrix Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 12, 1982 after a review of 77 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 Novametrix Medical Systems, Inc. devices

FDA 510(k) Submission Details - K813350

510(k) Number K813350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1981
Decision Date February 12, 1982
Days to Decision 77 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
63d faster than avg
Panel avg: 140d · This submission: 77d
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 K813350.
AS 30/TCP MODULE
K831460 · Narco Scientific · Jul 1983
IL 301 TRANSCUTANEOUS OXYGEN MONITOR
K822328 · Instrumentation Laboratory CO · Sep 1982
CRITIKON OXYGEN MONITOR, MODEL 8030
K821936 · Critikon Company, LLC · Aug 1982
CRITIKON TRANSCUTANEOUS GAS MONITORS
K813347 · Critikon Company, LLC · Jan 1982
NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN
K813352 · Novametrix Medical Systems, Inc. · Jan 1982
NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER
K813351 · Novametrix Medical Systems, Inc. · Dec 1981