510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950898Substantially Equivalent

Biobox with Funnel Top (Small, Medium, Large, and X-Large)

Biosystems S.A., Farmingdale NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950898 is the FDA 510(k) clearance record for BIOBOX WITH FUNNEL TOP (SMALL, MEDIUM, LARGE, AND X-LARGE), a class II device, cleared for Biosystems on under FDA product code MMK (Container, Sharps). FDA records list 7 510(k) clearances for Biosystems, from to . As of , FDA records show no recalls naming K950898.

Clearance record

Decision date
Received
(178 days to decision)
Product code
MMK Container, Sharps
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Biosystems 210 Sherwood Ave., Farmingdale NY
510(k) summary
Summary
Third party review
No

Clearances, product code MMK

Trailing 12 months
3 clearances under product code MMK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MMK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260