510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K992560Substantially Equivalent

Maps 10000

Web Link Medical, Beltsville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992560 is the FDA 510(k) clearance record for MAPS 10000, a class II device, cleared for Web Link Medical on under FDA product code KPS (System, Tomography, Computed, Emission). FDA records list one 510(k) clearance for Web Link Medical. As of , FDA records show no recalls naming K992560.

Clearance record

Decision date
Received
(88 days to decision)
Product code
KPS System, Tomography, Computed, Emission
Regulation
21 CFR 892.1200
Device class
Class II
Review panel
Radiology
Applicant
Web Link Medical 11800 Baltimore Ave., Beltsville MD
510(k) summary
Summary
Third party review
No

Clearances, product code KPS

Trailing 12 months
9 clearances under product code KPS in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KPS, trailing twelve months
MonthClearances
November 20251
December 20252
January 20261
February 20261
March 20260
April 20261
May 20261
June 20260
July 20261
August 20260
September 20261
October 20260