Cleared Traditional

K102270 - ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN

K102270 is an FDA 510(k) clearance for ENVITEC REUSABLE SPO2 SENSORS TYPE NIHO..., 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 196-day FDA review.

K102270 · Envitec-Wismar GmbH · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
196d
Days
Class 2
Risk

K102270 is an FDA 510(k) clearance for the ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Envitec-Wismar GmbH (Egale, US). The FDA issued a Cleared decision on February 22, 2011 after a review of 196 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.

FDA 510(k) Submission Details - K102270

510(k) Number K102270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2010
Decision Date February 22, 2011
Days to Decision 196 days
Submission Type Traditional
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
56d slower than avg
Panel avg: 140d · This submission: 196d
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 686
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K102270.
ENVISEN NELLCOR, BCI, NONIN, CSI, HP/PHILIPS, DATEX-OHMEDA COMPATIBLE DISPOSABLE AND REUSABLE SPO2 SENSORS
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MASIMO RADICAL Y PULSE CO-OXIMETER
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ESSENTIAL MRI PATIENT MONITOR
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PULSE OXIMETER MODEL P10
K100225 · Mediana Co., Ltd. · Feb 2011
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K101995 · Oridion Capnography, Inc. · Jan 2011
VITAL SIGNS MONITOR
K102835 · Edan Instruments, Inc. · Dec 2010