510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032061Unknown

Decathlon Twin Lumen Hemodialysis with Separated Tips, Models De19/24sh, De23/28sh, De27/32sh, De 31/36Sh, De19/24nh

Spire Biomedical, Inc., Bedford MA / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032061 is the FDA 510(k) clearance record for DECATHLON TWIN LUMEN HEMODIALYSIS WITH SEPARATED TIPS, MODELS DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH, DE19/24NH, a class II device, cleared for Spire Biomedical, Inc. on under FDA product code MSD (Catheter, Hemodialysis, Implanted). FDA records list 16 510(k) clearances for Spire Biomedical, Inc., from to . As of , FDA records show 48 recalls naming K032061.

Clearance record

Decision date
Received
(173 days to decision)
Product code
MSD Catheter, Hemodialysis, Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Spire Biomedical, Inc. One Patriots Park, Bedford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MSD

Trailing 12 months

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

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