510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K960966Substantially Equivalent

Hepa-Type Air Cleaner Model 2586 and True Hepa Air Cleaner Models 2587 and 2588

Sunbeam-Oster Household Products, Hattiesburg MS / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K960966 is the FDA 510(k) clearance record for HEPA-TYPE AIR CLEANER MODEL 2586 AND TRUE HEPA AIR CLEANER MODELS 2587 AND 2588, a class II device, cleared for Sunbeam-Oster Household Products on under FDA product code FRF (Cleaner, Air, Medical Recirculating). FDA records list one 510(k) clearance for Sunbeam-Oster Household Products. As of , FDA records show no recalls naming K960966.

Clearance record

Decision date
Received
(305 days to decision)
Product code
FRF Cleaner, Air, Medical Recirculating
Regulation
21 CFR 880.5045
Device class
Class II
Review panel
General Hospital
Applicant
Sunbeam-Oster Household Products 95 Wl Runnel Industrial Dr., Hattiesburg MS
510(k) summary
Statement
Third party review
No

Clearances, product code FRF

Trailing 12 months
1 clearance under product code FRF in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FRF, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260