Cleared Traditional

DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER (K874442) - FDA 510(k) Clearance

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

K874442 · Critikon Company, LLC · Anesthesiology device
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Feb 1988
Decision
113d
Days
Class 2
Risk

K874442 is an FDA 510(k) clearance for the DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Critikon Company, LLC (Tampa, US). The FDA issued a Cleared decision on February 18, 1988 after a review of 113 days - within the typical 510(k) review window.

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: 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 Critikon Company, LLC devices

Submission Details

510(k) Number K874442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date February 18, 1988
Days to Decision 113 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 140d · This submission: 113d
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 K874442.
OLV 1100
K881307 · Nihon Kohden America, Inc. · Nov 1988
HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER
K883297 · Hewlett-Packard Co. · Oct 1988
HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI.
K881136 · Hewlett-Packard Co. · May 1988
OHMEDA 4700 OXICAP MONITOR
K873199 · Ohmeda Medical · Feb 1988
OHMEDA BIOX 3760 PULSE OXIMETER
K874104 · Ohmeda Medical · Dec 1987
MODEL 7200A WITH PULSE OXIMETRY
K873065 · Puritan Bennett Corp. · Oct 1987