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Penlon Sigma Delta

by Penlon, Ltd.

Penlon Sigma Delta is a Class II device made by Penlon, Ltd., cleared under FDA 510(k) K002343 on 8 Jun 2001 and listed in FDA GUDID since 26 Jul 2016 (UDI-DI 05051977000116), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K002343

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05051977000116 UDI-DI Date26 Jul 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK002343 Date8 Jun 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K002343 decided 8 Jun 2001 Active
  • FDA GUDID UDI-DI 05051977000116 listed 26 Jul 2016 Listed

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.

Timeline

3 dated events

  1. Cleared FDA 510(k) K002343
  2. Recall initiated FDA recalls Z-1653-2013
  3. Listed FDA GUDID 05051977000116

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Penlon
Generic name
Enflurane anaesthesia vaporizer
Model / reference
Sigma Delta
Primary DI / UDI-DI
05051977000116
510(k) Number
FDA product code
CAD
GMDN term
Enflurane anaesthesia vaporizer
Device class
Class II
Regulation number
868.5880
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code CAD (Vaporizer, Anesthesia, Non-Heated).

Other devices from Penlon, Ltd.

See all devices from Penlon, Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)