510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K093473Substantially Equivalent

Kmd-Mark1 Tissue Marker

Kent Medical Devices, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093473 is the FDA 510(k) clearance record for KMD-MARK1 TISSUE MARKER, a class II device, cleared for Kent Medical Devices, Inc. on under FDA product code NEU (Marker, Radiographic, Implantable). FDA records list one 510(k) clearance for Kent Medical Devices, Inc. As of , FDA records show no recalls naming K093473.

Clearance record

Decision date
Received
(238 days to decision)
Product code
NEU Marker, Radiographic, Implantable
Regulation
21 CFR 878.4300
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Kent Medical Devices, Inc. 1331 H St. NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NEU

Trailing 12 months
4 clearances under product code NEU in the twelve months to October 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code NEU, trailing twelve months
MonthClearances
November 20250
December 20253
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260