510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863128Substantially Equivalent

Peritoneal Dialysis Catheters

Thermedics, Inc., Woburn MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863128 is the FDA 510(k) clearance record for PERITONEAL DIALYSIS CATHETERS, a class II device, cleared for Thermedics, Inc. on under FDA product code FJS (Catheter, Peritoneal, Long-Term Indwelling). FDA records list 4 510(k) clearances for Thermedics, Inc., from to . As of , FDA records show no recalls naming K863128.

Clearance record

Decision date
Received
(25 days to decision)
Product code
FJS Catheter, Peritoneal, Long-Term Indwelling
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Thermedics, Inc. 470 Wildwood St., Woburn MA
Third party review
No

Clearances, product code FJS

Trailing 12 months

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

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