510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K121458Substantially Equivalent

Speedicath Compact Set (12/18 Fr)

MEDLINE INDUSTRIES, LP - Northfield, Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121458 is the FDA 510(k) clearance record for SPEEDICATH COMPACT SET (12/18 FR), a class II device, cleared for Coloplast A/S on under FDA product code GBM (Catheter, Urethral). FDA records list 414 510(k) clearances for MEDLINE INDUSTRIES, LP - Northfield, from to . As of , FDA records show no recalls naming K121458.

Clearance record

Decision date
Received
(138 days to decision)
Product code
GBM Catheter, Urethral
Regulation
21 CFR 876.5130
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Coloplast A/S 1601 W. River Rd. N., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GBM

Trailing 12 months

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

FDA records show no clearances under product code GBM in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GBM, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260