Cleared Special

K100020 - DX SERIES FINGER SENSOR

K100020 is an FDA 510(k) clearance for DX SERIES FINGER SENSOR, manufactured by Dixtal Medical, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 62-day FDA review.

K100020 · Dixtal Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2010
Decision
62d
Days
Class 2
Risk

K100020 is an FDA 510(k) clearance for the DX SERIES FINGER SENSOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Dixtal Medical, Inc. (Wallingford, US). The FDA issued a Cleared decision on March 8, 2010 after a review of 62 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.

View all Dixtal Medical, Inc. devices

FDA 510(k) Submission Details - K100020

510(k) Number K100020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2010
Decision Date March 08, 2010
Days to Decision 62 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 140d · This submission: 62d
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 478
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K100020.
HANDHELD PULSE OXIMETER MODEL MD300A/ MD300K2/ MD300M
K100203 · Beijing Choice Electronic Technololgy Co., Ltd. · May 2010
LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS
K094046 · Masimo Corporation · May 2010
TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR
K093881 · GE Healthcare Finland Oy · Mar 2010
SINGLE-PATIENT USE DISPOSABLE SENSOR
K093306 · Nonin Medical, Inc. · Mar 2010
MD300C1 FINGERTIP PULSE OXIMETER
K093757 · Beijing Choice Electronic Technololgy Co., Ltd. · Mar 2010
FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA
K092652 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2010