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WorkMate Claris System

by Abbott

510(k) K210392

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK210392 Date11 Mar 2021ClearedStatusActive

Official records

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-1853-2021 FDA Class II initiated 5 May 2021
    • Terminated Z-1854-2021 FDA Class II initiated 5 May 2021
    • Terminated Z-1855-2021 FDA Class II initiated 5 May 2021

    Due to a software error, the user may lose functionality of the system or the screen may turn black during operation.

Timeline

4 dated events

  1. Cleared FDA 510(k) K210392
  2. Recall initiated FDA recalls Z-1853-2021
  3. Recall initiated FDA recalls Z-1854-2021
  4. Recall initiated FDA recalls Z-1855-2021

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  • Withdrawn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
DQK
Device class
Class II
Regulation
21 CFR Part 870.1425
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The WorkMate Claris System is a diagnostic computer designed for electrophysiology (EP) labs, enabling the collection, display, and storage of data from multiple sources. It integrates mapping, ablation, and patient monitoring functions to support cardiac arrhythmia diagnostics and treatment procedures, including atrial fibrillation (AFib).

This system is intended for use in clinical electrophysiology settings and is supplied as a reusable medical device. It is not classified as single-use and requires proper maintenance and calibration. The device holds FDA 510(k) clearance under K210392, with a special review designation under the Cardiovascular advisory committee. Sterility and MRI safety specifications are not detailed in the provided data.

Devices cleared under K210392

42 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K210392
UDI-DISize and differences
EP-4™ H700162
ST. JUDE MEDICAL, INC.
H700162 / H70016205415067001627 —On the market
WorkMate Claris™ H700123
ST. JUDE MEDICAL, INC.
H700123 / H70012305415067001238 —On the market
WorkMate Claris™ H700124
ST. JUDE MEDICAL, INC.
H700124 / H70012405415067001245 —On the market
WorkMate Claris™ H700128
ST. JUDE MEDICAL, INC.
H700128 / H70012805415067001283
Length 10 m
On the market
WorkMate Claris™ H700129
ST. JUDE MEDICAL, INC.
H700129 / H70012905415067001290
Length 15 m
On the market
WorkMate Claris™ H700130
ST. JUDE MEDICAL, INC.
H700130 / H70013005415067001306
Length 30 m
On the market
WorkMate Claris™ H700131
ST. JUDE MEDICAL, INC.
H700131 / H70013105415067001313 —On the market
WorkMate Claris™ H700133
ST. JUDE MEDICAL, INC.
H700133 / H70013305415067001337 —On the market
WorkMate Claris™ H700150
ST. JUDE MEDICAL, INC.
H700150 / H70015005415067001504 —On the market
WorkMate Claris™ H700151
ST. JUDE MEDICAL, INC.
H700151 / H70015105415067001511 —On the market
WorkMate Claris™ H700152
ST. JUDE MEDICAL, INC.
H700152 / H70015205415067001528 —On the market
WorkMate Claris™ H700153
ST. JUDE MEDICAL, INC.
H700153 / H70015305415067001535 —On the market
WorkMate Claris™ H700154
ST. JUDE MEDICAL, INC.
H700154 / H70015405415067001542 —On the market
WorkMate Claris™ H700155
ST. JUDE MEDICAL, INC.
H700155 / H70015505415067001559 —On the market
WorkMate Claris™ H700156
ST. JUDE MEDICAL, INC.
H700156 / H70015605415067001566 —On the market
WorkMate Claris™ H700157
ST. JUDE MEDICAL, INC.
H700157 / H70015705415067001573 —On the market
WorkMate Claris™ H700158
ST. JUDE MEDICAL, INC.
H700158 / H70015805415067001580 —On the market
WorkMate Claris™ H700159
ST. JUDE MEDICAL, INC.
H700159 / H70015905415067001597 —On the market
WorkMate Claris™ H700161
ST. JUDE MEDICAL, INC.
H700161 / H70016105415067001610 —On the market
WorkMate Claris™ H700169
ST. JUDE MEDICAL, INC.
H700169 / H70016905415067001696 —On the market
WorkMate Claris™ H700977
ST. JUDE MEDICAL, INC.
H700977 / H70097705415067009777 —On the market
WorkMate Claris™ H701312
ST. JUDE MEDICAL, INC.
H701312 / H70131205415067013125 —On the market
WorkMate Claris™ H701313
ST. JUDE MEDICAL, INC.
H701313 / H70131305415067013132 —On the market
WorkMate Claris™ H701703
ST. JUDE MEDICAL, INC.
H701703 / H70170305415067017031 —On the market
WorkMate Claris™ H701806
ST. JUDE MEDICAL, INC.
H701806 / H70180605415067018069 —On the market
WorkMate Claris™ H701807
ST. JUDE MEDICAL, INC.
H701807 / H70180705415067018076 —On the market
WorkMate Claris™ H800016
ST. JUDE MEDICAL, INC.
H800016 / H80001605415067047182 —On the market
WorkMate Claris™ H800017
ST. JUDE MEDICAL, INC.
H800017 / H80001705415067047175 —On the market
WorkMate Claris™ H800022
ST. JUDE MEDICAL, INC.
H800022 / H80002205415067047212 —On the market
WorkMate™ H700088
ST. JUDE MEDICAL, INC.
H700088 / H70008805415067000880 —On the market
WorkMate™ H700089
ST. JUDE MEDICAL, INC.
H700089 / H70008905415067000897 —On the market
WorkMate™ H700116
ST. JUDE MEDICAL, INC.
H700116 / H70011605415067001160 —On the market
WorkMate™ H700118
ST. JUDE MEDICAL, INC.
H700118 / H70011805415067001184 —On the market
WorkMate™ H700120
ST. JUDE MEDICAL, INC.
H700120 / H70012005415067001207 —On the market
WorkMate™ H700163
ST. JUDE MEDICAL, INC.
H700163 / H70016305415067001634 —On the market
WorkMate™ H701060
ST. JUDE MEDICAL, INC.
H701060 / H70106005415067010605 —On the market
WorkMate™ Scribe™ H800018
ST. JUDE MEDICAL, INC.
H800018 / H80001805415067047205 —On the market
WorkMate™ Unity™ H700147
ST. JUDE MEDICAL, INC.
H700147 / H70014705415067001474 —On the market
WorkMate™ Unity™ H700148
ST. JUDE MEDICAL, INC.
H700148 / H70014805415067001481 —On the market
WorkMate™ Unity™ H800019
ST. JUDE MEDICAL, INC.
H800019 / H80001905415067047168 —On the market
WorkMate™ Unity™ H800020
ST. JUDE MEDICAL, INC.
H800020 / H80002005415067047229 —On the market
WorkMate™ Unity™ H800021
ST. JUDE MEDICAL, INC.
H800021 / H80002105415067047199 —On the market

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