Cleared Traditional

K032509 - MARK 5 NUVO (M5C5)

K032509 is an FDA 510(k) clearance for MARK 5 NUVO (M5C5), manufactured by Nidek Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K032509 · Nidek Medical Products, Inc. · Anesthesiology device
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Mar 2004
Decision
217d
Days
Class 2
Risk

K032509 is an FDA 510(k) clearance for the MARK 5 NUVO (M5C5). Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Nidek Medical Products, Inc. (Birmingham, US). The FDA issued a Cleared decision on March 18, 2004 after a review of 217 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - 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 Nidek Medical Products, Inc. devices

FDA 510(k) Submission Details - K032509

510(k) Number K032509 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2003
Decision Date March 18, 2004
Days to Decision 217 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
77d slower than avg
Panel avg: 140d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 - CAW Generator, Oxygen, Portable

All 170
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K032509.
OXYTEC, MODEL 900
K043615 · Oxytec Medical Corporation · Feb 2005
INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10
K042262 · Sequal Technologies, Inc. · Sep 2004
PORTABLE OXYGEN GENERATION SYSTEM: POGS 33C
K041664 · On Site Gas Systems, Inc. · Jul 2004
VENTURE HOMEFILL II WITH OXYGEN CONSERVER
K021685 · Invacare Corp. · Jul 2002
INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02
K020386 · Invacare Corp. · Jul 2002
LIFESTYLE OXYGEN CONCENTRATOR
K020324 · Airsep Corp. · Mar 2002