Cleared Traditional

K970368 - SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER

K970368 is an FDA 510(k) clearance for SC9000/SC9015 MEDICAL INFORMATION BUS (..., manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K970368 · Siemens Medical Solutions USA, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
95d
Days
Class 2
Risk

K970368 is an FDA 510(k) clearance for the SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Danvers, US). The FDA issued a Cleared decision on May 6, 1997 after a review of 95 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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K970368

510(k) Number K970368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1997
Decision Date May 06, 1997
Days to Decision 95 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
45d faster than avg
Panel avg: 140d · This submission: 95d
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 587
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K970368.
MODULAR TELEMETRY SYSTEM (MTS) OPTION FOR THE MDE ESCORT II MONITOR
K970763 · Medical Data Electronics · Jul 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER GL625-W
K971235 · Alexander Mfg. Co. · Jun 1997
VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)
K964978 · Quinton, Inc. · May 1997
FLEXI-SITE (E203-01)/ FLEXI-FIT (E300)
K964055 · Epic Medical Equipment Services, Inc. · Feb 1997
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