Cleared Traditional

K002036 - OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD

K002036 is an FDA 510(k) clearance for OSI MEDICAL DOLPHIN STAND-ALONE PULSE O..., manufactured by Osi Medical, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K002036 · Osi Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
286d
Days
Class 2
Risk

K002036 is an FDA 510(k) clearance for the OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHI.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Osi Medical, Inc. (Tampa, US). The FDA issued a Cleared decision on April 17, 2001 after a review of 286 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 - K002036

510(k) Number K002036 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2000
Decision Date April 17, 2001
Days to Decision 286 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
146d slower than avg
Panel avg: 140d · This submission: 286d
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 K002036.
MEDLEY SP02 MODULE, MODEL 8220
K010966 · Alaris Medical Systems, Inc. · Jun 2001
SPO2 WRAP SENSOR
K002848 · Epic Medical Equipment Services, Inc. · May 2001
NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
K010451 · Novametrix Medical Systems, Inc. · Apr 2001
PREAMP CABLE, MODEL B400-1011PA
K003542 · Beta Biomed Services, Inc. · Apr 2001
FINGER PULSE METER
K000814 · Bhs Intl., Inc. · Mar 2001
DATEX-OHMEDA OXYGEN SATURATION MODULE, M-OSAT AND ACCESSOIRES
K010463 · Datex-Ohmeda, Inc. · Mar 2001
K002036 · OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER, MODEL 2100 AND DIGITAL DOLPHIN OPTICAL SENSOR, CLIP-ON FINGER PROBE, MOD
Download PDF FDA Summary Osi Medical, Inc.