510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K881356Substantially Equivalent

External Pacemaker Wire Dressing Change

Neal & Assoc., Inc., Columbia MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881356 is the FDA 510(k) clearance record for EXTERNAL PACEMAKER WIRE DRESSING CHANGE, a class II device, cleared for Neal & Assoc., Inc. on under FDA product code LDF (Electrode, Pacemaker, Temporary). FDA records list 2 510(k) clearances for Neal & Assoc., Inc., from to . As of , FDA records show no recalls naming K881356.

Clearance record

Decision date
Received
(52 days to decision)
Product code
LDF Electrode, Pacemaker, Temporary
Regulation
21 CFR 870.3680
Device class
Class II
Review panel
Cardiovascular
Applicant
Neal & Assoc., Inc. 6005 N. Gregory Dr., Columbia MO
Third party review
No

Clearances, product code LDF

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