Skip to content

Vital Signs Monitor W/Arrhythmia Detection and St Analysis, Model 8100

by Criticare Systems, Inc.

510(k) K030613

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK030613 Date17 Apr 2003ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-3253-2026 FDA Class II initiated 6 May 2026

    Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MHX
Device Class
Class II
Regulation
21 CFR Part 870.1025
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Criticare Systems, Inc.

See all devices from Criticare Systems, Inc. →