Cleared Traditional

K910077 - CRIT-SCAN

K910077 is an FDA 510(k) clearance for CRIT-SCAN, manufactured by Noninvasive Medical Technology Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 510-day FDA review.

K910077 · Noninvasive Medical Technology Corp. · Anesthesiology device
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Jun 1992
Decision
510d
Days
Class 2
Risk

K910077 is an FDA 510(k) clearance for the CRIT-SCAN. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Noninvasive Medical Technology Corp. (Ogden, US). The FDA issued a Cleared decision on June 2, 1992 after a review of 510 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 Noninvasive Medical Technology Corp. devices

FDA 510(k) Submission Details - K910077

510(k) Number K910077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1991
Decision Date June 02, 1992
Days to Decision 510 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
370d slower than avg
Panel avg: 140d · This submission: 510d
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 603
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K910077.
BIOCHEM MODEL 3301 NEWOX1 OXIMETER
K920082 · Biochem International, Inc. · Jan 1993
MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
K923682 · Hewlett-Packard Co. · Sep 1992
NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX
K920379 · Novametrix Medical Systems, Inc. · Jul 1992
SENSORMEDICS OXYSHUTTLE II(TM)
K913790 · Sensor Medics Corp. · Feb 1992
VITALMAX 510/520
K912880 · Pace Tech, Inc. · Nov 1991
NELLCOR(R) N-180 PULSE OXIMETER
K913695 · Nellcor, Inc. · Nov 1991