510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954278Substantially Equivalent

Beta Multi-Procedure Mobile Urological Table, Model S5005

Beta Medical Products Co., Akron OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954278 is the FDA 510(k) clearance record for BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005, a class II device, cleared for Beta Medical Products, Inc. on under FDA product code MMZ (Table, Cystometric, Electric). FDA records list 3 510(k) clearances for Beta Medical Products, Inc., from to . As of , FDA records show no recalls naming K954278.

Clearance record

Decision date
Received
(19 days to decision)
Product code
MMZ Table, Cystometric, Electric
Regulation
21 CFR 876.4890
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Beta Medical Products, Inc. 530 S. Main St., Bldg. 17, Akron OH
510(k) summary
Statement
Third party review
No

Clearances, product code MMZ

Trailing 12 months

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

FDA records show no clearances under product code MMZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MMZ, 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