Cleared Special

K024235 - DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER

K024235 is an FDA 510(k) clearance for DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER, manufactured by Dolphin Medical, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 84-day FDA review.

K024235 · Dolphin Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
84d
Days
Class 2
Risk

K024235 is an FDA 510(k) clearance for the DOLPHIN MEDICAL STAND-ALONE PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Dolphin Medical, Inc. (Tampa, US). The FDA issued a Cleared decision on March 17, 2003 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K024235

510(k) Number K024235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2002
Decision Date March 17, 2003
Days to Decision 84 days
Submission Type Special
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
56d faster than avg
Panel avg: 140d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

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 687
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K024235.
DOLPHIN 2000 PULSE OXIMETRY SENSORS MODELS 2010, 2311 ADULT, 2312 PEDIATRIC, 2313 INFANT, 2314 NEONATAL, 2421
K030952 · Dolphin Medical, Inc. · May 2003
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K031330 · Masimo Corp. · May 2003
MICROCAP PLUS/NPB-75
K024300 · Oridion Medical 1987 , Ltd. · Apr 2003
IM2001 PULSE OXIMETER
K012706 · Imagyn Medical Technologies, Inc. · Mar 2003
MINOLTA PULSOX-2
K021469 · Konica Minolta Sensing, Inc. · Feb 2003
VITALSAT SERIES
K011518 · Beta Biomed Services, Inc. · Nov 2002