Cleared Traditional

K924626 - NOVAMETRIX MODEL 510

K924626 is an FDA 510(k) clearance for NOVAMETRIX MODEL 510, manufactured by Novametrix Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 445-day FDA review.

K924626 · Novametrix Medical Systems, Inc. · Anesthesiology device
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Dec 1993
Decision
445d
Days
Class 2
Risk

K924626 is an FDA 510(k) clearance for the NOVAMETRIX MODEL 510. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Novametrix Medical Systems, Inc. (Wallingford, US). The FDA issued a Cleared decision on December 3, 1993 after a review of 445 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Novametrix Medical Systems, Inc. devices

FDA 510(k) Submission Details - K924626

510(k) Number K924626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1992
Decision Date December 03, 1993
Days to Decision 445 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
305d slower than avg
Panel avg: 140d · This submission: 445d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K924626.
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