Cleared Traditional

K982499 - COSMO PLUS WITH NICO, MODEL 8200

K982499 is an FDA 510(k) clearance for COSMO PLUS WITH NICO, manufactured by Novametrix Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BZC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K982499 · Novametrix Medical Systems, Inc. · Anesthesiology device
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Oct 1998
Decision
88d
Days
Class 2
Risk

K982499 is an FDA 510(k) clearance for the COSMO PLUS WITH NICO, MODEL 8200. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Novametrix Medical Systems, Inc. (Wallingford, US). The FDA issued a Cleared decision on October 16, 1998 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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 - K982499

510(k) Number K982499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1998
Decision Date October 16, 1998
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZC Device Classification - Class 2, Special Controls

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 49
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K982499.
COSMED QUARK
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K982487 · Cardiopulmonary Technologies, Inc. · Oct 1998
INTELLIFLOW RESPIRATORY ANALYZER
K970840 · Simtec, Inc. · Nov 1997
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K963373 · Cosmed Srl · Sep 1997