Cleared Traditional

K960831 - VENTRAK RMMS 1550

K960831 is an FDA 510(k) clearance for VENTRAK RMMS 1550, 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 90-day FDA review.

K960831 · Novametrix Medical Systems, Inc. · Anesthesiology device
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May 1996
Decision
90d
Days
Class 2
Risk

K960831 is an FDA 510(k) clearance for the VENTRAK RMMS 1550. 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 May 29, 1996 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Novametrix Medical Systems, Inc. devices

FDA 510(k) Submission Details - K960831

510(k) Number K960831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 1996
Decision Date May 29, 1996
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
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 24
Devices cleared under the same product code (BZC) and FDA review panel - the closest regulatory comparables to K960831.
COSMO PLUS WITH NICO, MODEL 8200
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VENT(VENTCHECK) HANDHELD RESPIRATORY/MECHANICS MONITOR MODEL 101
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CO 2 SMO PLUS
K963380 · Novametrix Medical Systems, Inc. · Jan 1997
ACKRAD ESOPHAGEAL BALLOON CATHETER SET
K952542 · Ackrad Laboratories · Apr 1996
SENSORMEDICS MODEL 2600 PEDIATRIC PULMOONARY CART
K915833 · Sensor Medics Corp. · Dec 1992
MODEL 2900 METABOLIC MEASUREMENT CART
K915686 · Sensor Medics Corp. · Dec 1992