510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831029Substantially Equivalent

Hemoperfusion System Tp-400

Extracorporeal Medical Specialities, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831029 is the FDA 510(k) clearance record for HEMOPERFUSION SYSTEM TP-400, a class II device, cleared for Extracorporeal Medical Specialities, Inc. on under FDA product code FLD (Apparatus, Hemoperfusion, Sorbent). FDA records list 69 510(k) clearances for Extracorporeal Medical Specialities, Inc., from to . As of , FDA records show no recalls naming K831029.

Clearance record

Decision date
Received
(149 days to decision)
Product code
FLD Apparatus, Hemoperfusion, Sorbent
Regulation
21 CFR 876.5870
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Extracorporeal Medical Specialities, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code FLD

Trailing 12 months

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

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