510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K811232Substantially Equivalent

Disposable Underpads

Burina, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811232 is the FDA 510(k) clearance record for DISPOSABLE UNDERPADS, a class I device, cleared for Burina on under FDA product code KME (Bedding, Disposable, Medical). FDA records list one 510(k) clearance for Burina. As of , FDA records show no recalls naming K811232.

Clearance record

Decision date
Received
(17 days to decision)
Product code
KME Bedding, Disposable, Medical
Regulation
21 CFR 880.6060
Device class
Class I
Review panel
General Hospital
Applicant
Burina 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KME

Trailing 12 months

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

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