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Sigma Delta

by Penlon Limited

510(k) K002343

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 · Traditional NumberK002343 Date8 Jun 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1653-2013 FDA Class II initiated 14 May 2013

    It has come to Penlon Ltd's attention of an instance where the installation and pre-use checks listed in the User Manual may not have been followed prior to the clinical use of the vaporizer. Penlon Ltd has updated the Installation and daily Pre-Use Check sections of the User Manual to ensure that the instructions are explicit and clear.

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  • Withdrawn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
CAD
FDA applicant
Penlon , Ltd.
Device Class
Class II
Regulation
21 CFR Part 868.5880
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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