Cleared Traditional

K813351 - NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER

K813351 is an FDA 510(k) clearance for NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER, 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 34-day FDA review.

K813351 · Novametrix Medical Systems, Inc. · Anesthesiology device
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Dec 1981
Decision
34d
Days
Class 2
Risk

K813351 is an FDA 510(k) clearance for the NOVAMETRIX NAVAGRAPH MODEL 312 RECORDER. 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 December 31, 1981 after a review of 34 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 - K813351

510(k) Number K813351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1981
Decision Date December 31, 1981
Days to Decision 34 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
106d faster than avg
Panel avg: 140d · This submission: 34d
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 K813351.
NOVAMETRIX MODEL 807 TRANSCUT. MONITOR
K813350 · Novametrix Medical Systems, Inc. · Feb 1982
CRITIKON TRANSCUTANEOUS GAS MONITORS
K813347 · Critikon Company, LLC · Jan 1982
NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN
K813352 · Novametrix Medical Systems, Inc. · Jan 1982
MODEL 78850 OXYGEN MONITOR
K812167 · Hewlett-Packard Co. · Aug 1981
CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS
K810999 · Cordis Corp. · Jun 1981
LIFESPAN 100
K811470 · Biochem International, Inc. · Jun 1981