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Ep-Workmate System, Version 4.2

by St Jude Medical

510(k) K092810

Ep-Workmate System, Version 4.2 is a Class II device made by St Jude Medical, cleared under FDA 510(k) K092810 on 9 Oct 2009, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK092810 Date9 Oct 2009ClearedStatusActive

Official records

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  • Withdrawn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

Devices cleared under K092810

10 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 K092810
UDI-DISize and differences
EP-NurseMate™ H700097
ST. JUDE MEDICAL, INC.
H700097 / H70009705415067000972 —On the market
EP-WorkMate™ 09-0080-0000
ST. JUDE MEDICAL, INC.
09-0080-0000 / 09-0080-000005415067003461 —On the market
EP-WorkMate™ 100019209
ST. JUDE MEDICAL, INC.
100019209 / 10001920905415067003126 —On the market
EP-WorkMate™ 100041650
ST. JUDE MEDICAL, INC.
100041650 / 10004165005415067003553 —On the market
EP-WorkMate™ H700086
ST. JUDE MEDICAL, INC.
H700086 / H70008605415067000866 —On the market
EP-WorkMate™ Recording System
ST. JUDE MEDICAL, INC.
100043247 / Recording System05415067003560 —On the market
EP-WorkMate™ Recording System
ST. JUDE MEDICAL, INC.
H21910 / Recording System05414734219105 —On the market
EP-WorkMate™ Recording System
ST. JUDE MEDICAL, INC.
H700096 / Recording System05415067000965 —On the market
EP-WorkMate™ System
ST. JUDE MEDICAL, INC.
09-1463-0120 / System05415067003119 —On the market
EP-WorkMate™ WM-01-1203
ST. JUDE MEDICAL, INC.
WM-01-1203 / WM-01-120305414734207546 —On the market

Similar devices

Other devices filed under FDA product code DQK (Computer, Diagnostic, Programmable).

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