Cleared Traditional

INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF (K971273) - FDA 510(k) Clearance

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

K971273 · Bio-Tek Instruments, Inc. · Anesthesiology device
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Oct 1997
Decision
184d
Days
Class 2
Risk

K971273 is an FDA 510(k) clearance for the INDEX 2E, INDEX 2F, INDEX 2EF, CARDIOSAT 100E, CARDIOSAT 100F, CARDIOSAT 100EF. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Bio-Tek Instruments, Inc. (Winooski, US). The FDA issued a Cleared decision on October 8, 1997 after a review of 184 days - an extended review cycle.

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 Bio-Tek Instruments, Inc. devices

Submission Details

510(k) Number K971273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1997
Decision Date October 08, 1997
Days to Decision 184 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 139d · This submission: 184d
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 159
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K971273.
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K974292 · Nihon Kohden America, Inc. · Jun 1998
CRICKET 2000 RECORDING PULSE OXIMETER
K972829 · Respironics, Inc. · Oct 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K973222 · Siemens Medical Solutions USA, Inc. · Sep 1997
VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)
K964978 · Quinton, Inc. · May 1997
SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER
K970368 · Siemens Medical Solutions USA, Inc. · May 1997