510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K081313Substantially Equivalent

Sh14 Hemoconcentrator

Corcym Inc., Waltham MA / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081313 is the FDA 510(k) clearance record for SH14 HEMOCONCENTRATOR, a class II device, cleared for Sorin Group Italia S.R.L. on under FDA product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System). FDA records list 64 510(k) clearances for Corcym Inc., from to . As of , FDA records show no recalls naming K081313.

Clearance record

Decision date
Received
(194 days to decision)
Product code
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Sorin Group Italia S.R.L. 200 W. St., Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KDI

Trailing 12 months
7 clearances under product code KDI in the twelve months to November 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KDI, trailing twelve months
MonthClearances
December 20251
January 20261
February 20261
March 20261
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20261
November 20260