510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162503Substantially Equivalent

Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software

Cardiac Insight, Inc., Kirkland WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162503 is the FDA 510(k) clearance record for Stealth System, Stealth Sensor, Stealth Smart Cable, StealthView Software, a class II device, cleared for Cardiac Insight, Inc. on under FDA product code DSH (Recorder, Magnetic Tape, Medical). FDA records list 3 510(k) clearances for Cardiac Insight, Inc., from to . As of , FDA records show no recalls naming K162503.

Clearance record

Decision date
Received
(198 days to decision)
Product code
DSH Recorder, Magnetic Tape, Medical
Regulation
21 CFR 870.2800
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiac Insight, Inc. 3230 Carillon Pt., Kirkland WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DSH

Trailing 12 months
3 clearances under product code DSH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DSH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260