Cleared Traditional

K952315 - SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE

K952315 is an FDA 510(k) clearance for SATMASTER, manufactured by Emg Scientific. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 567-day FDA review.

K952315 · Emg Scientific · Anesthesiology device
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Dec 1996
Decision
567d
Days
Class 2
Risk

K952315 is an FDA 510(k) clearance for the SATMASTER, COMPUTERIZED PULSE OXIMETRY SOFTWARE. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Emg Scientific (Los Angeles, US). The FDA issued a Cleared decision on December 4, 1996 after a review of 567 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 Emg Scientific devices

FDA 510(k) Submission Details - K952315

510(k) Number K952315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1995
Decision Date December 04, 1996
Days to Decision 567 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
427d slower than avg
Panel avg: 140d · This submission: 567d
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 K952315.
8500A PULSE OXIMETER
K945290 · Nonin Medical, Inc. · Feb 1997
MASIMO SET MS-1 PULSE OXIMETER & THE LNOP SERIES OF SENSORS & CABLES
K962603 · Masimo Corp. · Feb 1997
NELLCOR PURITAN BENNETT NPB-40 HANDHELD PULSE(NPB-40)
K963707 · Nellcor Puritan Bennett, Inc. · Dec 1996
OXI TEMP
K963496 · Bci Intl., Inc. · Nov 1996
OHMEDA 3800 PULSE OXIMETER
K962127 · Ohmeda Medical · Oct 1996
E100A PULSE OXIMETER FINGER SENSOR/PROBE
K954168 · Epic Medical Equipment Services, Inc. · Sep 1996