Plaxtron Suction Unit, Model 88AA51/88AA61 Series

510(k) K120065

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK120065	Date3 Apr 2012Cleared	StatusActive

3 recalls · 1 ongoing · FDA

- Ongoing Z-1341-2026 FDA Class II initiated 13 Jan 2026
units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.
- Terminated Z-0868-2021 FDA Class II initiated 18 Dec 2020
Component failures may cause the unit to lose all suction. Users will need to obtain alternate suction devices or methods, leading to a delay in treatment and, in worst case scenario, potential suffocation if alternative suction or ventilation method is not administered by the user.
- Terminated Z-0973-2018 FDA Class II initiated 31 Aug 2017
A shipment of LCSU 4 suction units and canisters attempted importation into the United States but was refused by FDA for lack of necessary approvals with CDRH by the foreign firms.

1 jurisdiction

United States — FDA 510(k) Active

510(k)