Cleared Special

K103700 - ESSENTIAL MRI PATIENT MONITOR

K103700 is an FDA 510(k) clearance for ESSENTIAL MRI PATIENT MONITOR, manufactured by Invivo Corporation. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 85-day FDA review.

K103700 · Invivo Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
85d
Days
Class 2
Risk

K103700 is an FDA 510(k) clearance for the ESSENTIAL MRI PATIENT MONITOR. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Invivo Corporation (Orlando, US). The FDA issued a Cleared decision on March 15, 2011 after a review of 85 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 - K103700

510(k) Number K103700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2010
Decision Date March 15, 2011
Days to Decision 85 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
55d faster than avg
Panel avg: 140d · This submission: 85d
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 K103700.
PULSE OXIMETER SENSOR (DISPOSABLE AND REUSABLE) MODEL RSA002DN, RSJ002DA, RSJ091DI, RST063CA
K103685 · Beijing Rongrui-Century Scie. & Tech. Co., Ltd. · Jul 2011
ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS
K103584 · Shenzhen Envisen Industry Co. Limited · Jun 2011
MASIMO RADICAL Y PULSE CO-OXIMETER
K110028 · Masimo Corporation · Mar 2011
ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN
K102270 · Envitec-Wismar GmbH · Feb 2011
PULSE OXIMETER MODEL P10
K100225 · Mediana Co., Ltd. · Feb 2011
CAPNOSTREAM 20P WITH MASIMO SPO2 BOARD
K101995 · Oridion Capnography, Inc. · Jan 2011