Cleared Special

ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS (K060675) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K060675 · Envitec-Wismar GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
125d
Days
Class 2
Risk

K060675 is an FDA 510(k) clearance for the ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Envitec-Wismar GmbH (Egale, US). The FDA issued a Cleared decision on July 17, 2006 after a review of 125 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Envitec-Wismar GmbH devices

Submission Details

510(k) Number K060675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2006
Decision Date July 17, 2006
Days to Decision 125 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
15d faster than avg
Panel avg: 140d · This submission: 125d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 190
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K060675.
PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T
K062605 · Philips Medical Systems · Nov 2006
PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL
K062455 · Philips Medical Systems · Nov 2006
PULSE OXIMETER, MODEL PM-50
K061442 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2006
WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE
K053381 · Welch Allyn, Inc. · Jun 2006
PM-50 PULSE OXIMETER
K052693 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2006
DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT
K052755 · Ge Healthcare · Oct 2005