510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870221Substantially Equivalent

T.o.p. 2000 (Tomographic Orientated Planning)

Kermath Mfg. Corp., Rolling Meadows IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870221 is the FDA 510(k) clearance record for T.O.P. 2000 (TOMOGRAPHIC ORIENTATED PLANNING), a class II device, cleared for Kermath Mfg. Corp. on under FDA product code KPQ (System, Simulation, Radiation Therapy). FDA records list 5 510(k) clearances for Kermath Mfg. Corp., from to . As of , FDA records show no recalls naming K870221.

Clearance record

Decision date
Received
(111 days to decision)
Product code
KPQ System, Simulation, Radiation Therapy
Regulation
21 CFR 892.5840
Device class
Class II
Review panel
Radiology
Applicant
Kermath Mfg. Corp. 5105 Tollview Dr. Suite 170, Rolling Meadows IL
Third party review
No

Clearances, product code KPQ

Trailing 12 months

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

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