Cleared Traditional

K962127 - OHMEDA 3800 PULSE OXIMETER

K962127 is an FDA 510(k) clearance for OHMEDA 3800 PULSE OXIMETER, manufactured by Ohmeda Medical. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K962127 · Ohmeda Medical · Anesthesiology device
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Oct 1996
Decision
129d
Days
Class 2
Risk

K962127 is an FDA 510(k) clearance for the OHMEDA 3800 PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Ohmeda Medical (Madison, US). The FDA issued a Cleared decision on October 10, 1996 after a review of 129 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 Ohmeda Medical devices

FDA 510(k) Submission Details - K962127

510(k) Number K962127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1996
Decision Date October 10, 1996
Days to Decision 129 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
11d faster than avg
Panel avg: 140d · This submission: 129d
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 577
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K962127.
NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)
K963707 · Nellcor Puritan Bennett, Inc. · Dec 1996
SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE
K952315 · Emg Scientific · Dec 1996
OXI TEMP
K963496 · Bci Intl., Inc. · Nov 1996
E100A PULSE OXIMETER FINGER SENSOR/PROBE
K954168 · Epic Medical Equipment Services, Inc. · Sep 1996
3304 PULSE OXIMETER
K962156 · Bci Intl., Inc. · Aug 1996
SCORE SOFTWARE
K961450 · Nellcor Puritan Bennett, Inc. · Aug 1996