Cleared Special

K014294 - MODIFICATION TO ESCORT II+ 400 SERIES 9...

K014294 is an FDA 510(k) clearance for MODIFICATION TO ESCORT II+ 400 SERIES 9..., manufactured by Medical Data Electronics. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 28-day FDA review.

K014294 · Medical Data Electronics · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
28d
Days
Class 2
Risk

K014294 is an FDA 510(k) clearance for the MODIFICATION TO ESCORT II+ 400 SERIES 9ESCORT PRISM) MONITOR, MODELS 20400, 2.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Medical Data Electronics (Arleta, US). The FDA issued a Cleared decision on January 25, 2002 after a review of 28 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 Medical Data Electronics devices

FDA 510(k) Submission Details - K014294

510(k) Number K014294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2001
Decision Date January 25, 2002
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K014294.
OXIMAX N-550 PULSE OXIMETER,MODEL N-550 PULSE OXIMETER
K021090 · Nellcor Puritan Bennett, Inc. · May 2002
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, M-NSAT AND ACCESSORIES
K020479 · Datex-Ohmeda · 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
NONIN MODEL 2120 PULSE OXIMETER AND NONINVASIVE BLOOD PRESSURE (NIBP) MONITOR
K013319 · Nonin Medical, Inc. · Jan 2002
FUKUDA DENSHI MODEL HG-500, PULSE OXIMETER MODULE
K013273 · Fukuda Denshi USA, Inc. · Dec 2001
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K013792 · Masimo Corp. · Dec 2001