Cleared Traditional

K090438 - REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/...

K090438 is an FDA 510(k) clearance for REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/..., 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 154-day FDA review.

K090438 · Envitec-Wismar GmbH · Anesthesiology device
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Jul 2009
Decision
154d
Days
Class 2
Risk

K090438 is an FDA 510(k) clearance for the REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2.... 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 24, 2009 after a review of 154 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 - K090438

510(k) Number K090438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2009
Decision Date July 24, 2009
Days to Decision 154 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 140d · This submission: 154d
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 K090438.
DISPOSABLE SPO2 SENSOR M1134A
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MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP
K090662 · Masimo Corporation · Aug 2009
MD300K1 PULSE OXIMETER
K090599 · Beijing Choice Electronic Technololgy Co., Ltd. · Jul 2009
RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20
K090165 · Masimo Corporation · Jul 2009
MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES
K091057 · Masimo Corporation · Jul 2009