510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K900871Substantially Equivalent

Alternating Pressure Pump and Pad System

Three Bears Intl., New Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900871 is the FDA 510(k) clearance record for ALTERNATING PRESSURE PUMP AND PAD SYSTEM, a class II device, cleared for Three Bears Intl. on under FDA product code FNM (Mattress, Air Flotation, Alternating Pressure). FDA records list one 510(k) clearance for Three Bears Intl. As of , FDA records show no recalls naming K900871.

Clearance record

Decision date
Received
(39 days to decision)
Product code
FNM Mattress, Air Flotation, Alternating Pressure
Regulation
21 CFR 880.5550
Device class
Class II
Review panel
General Hospital
Applicant
Three Bears Intl. 374 Hawthorn St., New Bedford MA
Third party review
No

Clearances, product code FNM

Trailing 12 months

FDA records hold no clearances under product code FNM in the trailing twelve months.

FDA records show no clearances under product code FNM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FNM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260