Cleared Traditional

K960966 - HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588

K960966 is an FDA 510(k) clearance for HEPA-TYPE AIR CLEANER MODEL 2586 AND TR..., manufactured by Sunbeam-Oster Household Products. The device is a Class 2 General Hospital device with product code FRF cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K960966 · Sunbeam-Oster Household Products · General Hospital
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Jan 1997
Decision
305d
Days
Class 2
Risk

K960966 is an FDA 510(k) clearance for the HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588. Classified as Cleaner, Air, Medical Recirculating (product code FRF), Class II - Special Controls.

Submitted by Sunbeam-Oster Household Products (Hattiesburg, US). The FDA issued a Cleared decision on January 10, 1997 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5045 - 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 Sunbeam-Oster Household Products devices

FDA 510(k) Submission Details - K960966

510(k) Number K960966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1996
Decision Date January 10, 1997
Days to Decision 305 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 129d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRF Device Classification - Class 2, Special Controls

Product Code FRF Cleaner, Air, Medical Recirculating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5045
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 - FRF Cleaner, Air, Medical Recirculating

All 16
Devices cleared under the same product code (FRF) and FDA review panel - the closest regulatory comparables to K960966.
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BREATHE EASY, MODELS AD AND CD
K981841 · Respiraid , Ltd. · Oct 1998
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K974682 · Biological Controls, Inc. · Jan 1998
NORELCO CLEAN AIR SYSTEM CAS950
K945161 · Hogan & Hartson · Nov 1994
FILTER, PARTICULATE ARRESTING
K760481 · Miles Laboratories, Inc. · Sep 1976