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Prima Anaesthesia Machine

by Penlon Limited

510(k) K061102

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 · Special NumberK061102 Date28 Jul 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1318-2012 FDA Unclassified (pre-2012) initiated 29 Nov 2011

    Penlon, Ltd has identified the potential for the premature failure of a component in some Electronic Flowmeter sensor display unit PCB assemblies.

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  • Withdrawn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
BSZ
FDA applicant
Penlon , Ltd.
Device Class
Class II
Regulation
21 CFR Part 868.5160
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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