510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781234Substantially Equivalent

Tubes, Lukens, Tomas

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

K781234 is the FDA 510(k) clearance record for TUBES, LUKENS, TOMAS, a class II device, cleared for Ludwig Medical, Inc. on under FDA product code KDQ (Bottle, Collection, Vacuum). FDA records list one 510(k) clearance for Ludwig Medical, Inc. As of , FDA records show no recalls naming K781234.

Clearance record

Decision date
Received
(22 days to decision)
Product code
KDQ Bottle, Collection, Vacuum
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Ludwig Medical, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KDQ

Trailing 12 months

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

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