Cleared Traditional

PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES (K120065) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120065 · Plaxtron Industrial (M) Sdn. Bhd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
85d
Days
Class 2
Risk

K120065 is an FDA 510(k) clearance for the PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Plaxtron Industrial (M) Sdn. Bhd. (Kaohsiung City, TW). The FDA issued a Cleared decision on April 3, 2012 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4780 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Plaxtron Industrial (M) Sdn. Bhd. devices

Submission Details

510(k) Number K120065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2012
Decision Date April 03, 2012
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JCX Apparatus, Suction, Ward Use, Portable, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4780
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - JCX Apparatus, Suction, Ward Use, Portable, Ac-powered

All 76
Devices cleared under the same product code (JCX) and FDA review panel - the closest regulatory comparables to K120065.
Protable Phlegm Suction Unit (JMA D01)
K250964 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · May 2026
MV Flow Aspiration Pump (MVFLOWPMP01)
K243638 · Microvention · Jun 2025
Cary
K251111 · Excitus AS · May 2025
Riptide™ Aspiration Pump
K243418 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Dec 2024
Easycess Aspiration Pump
K233428 · Guangzhou Easycess Medical Co.,Ltd · Nov 2023
120V Neptune S Rover (0711-001-000)
K222552 · Stryker Instruments · Dec 2022