510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K021987Substantially Equivalent

Parcomplast Compensating Filter for Radiation Therapy

S&S Par Scientific, Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021987 is the FDA 510(k) clearance record for PARCOMPLAST COMPENSATING FILTER FOR RADIATION THERAPY, a class II device, cleared for S&S Par Scientific on under FDA product code IXI (Block, Beam-Shaping, Radiation Therapy). FDA records list 2 510(k) clearances for S&S Par Scientific, from to . As of , FDA records show no recalls naming K021987.

Clearance record

Decision date
Received
(192 days to decision)
Product code
IXI Block, Beam-Shaping, Radiation Therapy
Regulation
21 CFR 892.5710
Device class
Class II
Review panel
Radiology
Applicant
S&S Par Scientific 55 Northern Blvd., Suite 200, Great Neck NY
510(k) summary
Summary PDF
Third party review
No

Clearances, product code IXI

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