Cleared Traditional

NOVAMETRIX MODEL 510 (K924626) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 189
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K924626.
OHMEDA 3800 PULSE OXIMETER
K962127 · Ohmeda Medical · Oct 1996
HP M1722A/B AND M1723A/B CODEMASTER
K944608 · Hewlett-Packard Co. · Oct 1994
OHMEDA HAND HELD OXIMETER
K931304 · Ohmeda Medical · Sep 1994
HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER
K923343 · Hewlett-Packard Co. · Feb 1993
MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
K923682 · Hewlett-Packard Co. · Sep 1992
CIBA CORNING MODEL 270 CO-OXIMETER
K913332 · Ciba Corning Diagnostics Corp. · Oct 1991