Cleared Traditional

K043359 - 4100 PATIENT OXIMETER MODULE

K043359 is an FDA 510(k) clearance for 4100 PATIENT OXIMETER MODULE, manufactured by Nonin Medical, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K043359 · Nonin Medical, Inc. · Anesthesiology device
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Jan 2005
Decision
32d
Days
Class 2
Risk

K043359 is an FDA 510(k) clearance for the 4100 PATIENT OXIMETER MODULE. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on January 7, 2005 after a review of 32 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nonin Medical, Inc. devices

FDA 510(k) Submission Details - K043359

510(k) Number K043359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2004
Decision Date January 07, 2005
Days to Decision 32 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
108d faster than avg
Panel avg: 140d · This submission: 32d
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 665
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K043359.
ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS
K043463 · Envitec-Wismar GmbH · Feb 2005
LNOPV AD-L AND PD-L OXIMETRY SENSORS
K050068 · Masimo Corporation · Feb 2005
MASIMO SET RAD 57 PULSE CO-OXIMETER
K042536 · Masimo Corporation · Jan 2005
DISPOSABLE NON-ADHESIVE SPO2 SENSORS
K042705 · Elekon Industries U.S.A., Inc. · Dec 2004
PMP4 OXY PRO
K043162 · Card Guard Scientific Survival , Ltd. · Dec 2004
REUSABLE FINGER CLIP SPO2 SENSORS
K042704 · Elekon Industries U.S.A., Inc. · Nov 2004