510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K914105Substantially Equivalent

Cathwriter(tm)

Softheart, Inc., South Burlington VT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914105 is the FDA 510(k) clearance record for CATHWRITER(TM), a class II device, cleared for Softheart, Inc. on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list 3 510(k) clearances for Softheart, Inc., from to . As of , FDA records show no recalls naming K914105.

Clearance record

Decision date
Received
(166 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
Softheart, Inc. 38 Brewer Pkwy., South Burlington VT
510(k) summary
Statement
Third party review
No

Clearances, product code DQK

Trailing 12 months
26 clearances under product code DQK in the twelve months to October 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
November 20250
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20261