Cleared Traditional

K011974 - SENSAID

K011974 is an FDA 510(k) clearance for SENSAID, manufactured by Sensidyne, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K011974 · Sensidyne, Inc. · Anesthesiology device
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Feb 2002
Decision
232d
Days
Class 2
Risk

K011974 is an FDA 510(k) clearance for the SENSAID. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Sensidyne, Inc. (Clearwater, US). The FDA issued a Cleared decision on February 12, 2002 after a review of 232 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.

FDA 510(k) Submission Details - K011974

510(k) Number K011974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2001
Decision Date February 12, 2002
Days to Decision 232 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 140d · This submission: 232d
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 726
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K011974.
DOLPHIN 2000 OXIMETRY SENSOR, MODELS, 2050, 2351, 2354, 2070
K012989 · Dolphin Medical, Inc. · Mar 2002
OXIMAX PULSE OXIMETRY SYSTEM WITH N-595 PULSE OXIMETER AND OXIMAX SENSORS AND CABLES (AKA ACCESSORIES)
K012891 · Nellcor Puritan Bennett, Inc. · Mar 2002
BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM
K013862 · Bci, Inc. · Feb 2002
MODIFICATION TO OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER
K020075 · Dolphin Medical, Inc. · Feb 2002
MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 20401, 20403, 20411, 20412, 20413, 20414
K014294 · Medical Data Electronics · Jan 2002
3420 DIGIT PULSE OXIMETER, MODEL 3420
K013171 · Bci, Inc. · Jan 2002
K011974 · SENSAID
Download PDF Sensidyne, Inc.