Cleared Traditional

K992215 - MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR

K992215 is an FDA 510(k) clearance for MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, manufactured by Envitec-Wismar GmbH. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K992215 · Envitec-Wismar GmbH · Anesthesiology device
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Mar 2000
Decision
272d
Days
Class 2
Risk

K992215 is an FDA 510(k) clearance for the MULTICOMPATIBLE ENVITEC FINGER CLIP SENSOR, MULTICOMPATIBLE ENVITEC ADULT DIS.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Envitec-Wismar GmbH (Fond Du Lac, US). The FDA issued a Cleared decision on March 29, 2000 after a review of 272 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Envitec-Wismar GmbH devices

FDA 510(k) Submission Details - K992215

510(k) Number K992215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1999
Decision Date March 29, 2000
Days to Decision 272 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 140d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K992215.
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE, MASIMO LNOP-ADT-ADULT/PEDIATRIC DISPOSABLE SENSOR, MASIMO LNO-PDT-PEDIA
K000126 · Masimo Corp. · Apr 2000
MODIFICATION TO MARSPO2, MODEL 2001
K000794 · Novametrix Medical Systems, Inc. · Apr 2000
DATEX-OHMEDA TUFFSAT 3000 PULSE OXIMETER
K993512 · Datex-Ohmeda, Inc. · Mar 2000
MARSPO2, MODEL 2001
K993979 · Novametrix Medical Systems, Inc. · Feb 2000
NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES
K992455 · Nihon Kohden America, Inc. · Jan 2000
SPACELABS MEDICAL DISPOSABLE SP02 SENSOR
K981655 · Spacelabs Medical, Inc. · Dec 1999