Cleared Traditional

K102483 - SUNSET HEALTHCARE SOLUTIONS BACTERIAL/V...

K102483 is an FDA 510(k) clearance for SUNSET HEALTHCARE SOLUTIONS BACTERIAL/V..., manufactured by Sunset Healthcare Solutions, LLC. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K102483 · Sunset Healthcare Solutions, LLC · General Hospital
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Sep 2011
Decision
379d
Days
Class 2
Risk

K102483 is an FDA 510(k) clearance for the SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Sunset Healthcare Solutions, LLC (Greenwood Village, US). The FDA issued a Cleared decision on September 13, 2011 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Sunset Healthcare Solutions, LLC devices

FDA 510(k) Submission Details - K102483

510(k) Number K102483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2010
Decision Date September 13, 2011
Days to Decision 379 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
250d slower than avg
Panel avg: 129d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 84
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K102483.
SafeBreath Filter Mouthpiece
K190022 · MD Diagnostics Limited · Sep 2019
RT016 INSPIRATORY FILTER
K133666 · Fisher &Paykel Healthcare , Ltd. · Feb 2014
HUMID-VENT HEPA
K112958 · Teleflex Medical · Sep 2012
RT019 INSPIRATORY/EXPIRATORY FILTER
K050927 · Fisher &Paykel Healthcare , Ltd. · Aug 2005
MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER
K043120 · Datex-Ohmeda, Inc. · Mar 2005
VENTLAB BACTERIAL FILTER, MODEL BF100
K030271 · Ventlab Corp. · Jul 2003