Cleared Traditional

K900430 - IRRIGATION AND SUCTION APPARATUS (FDA 510(k) Clearance)

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

K900430 · Acorn Group, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
126d
Days
Class 2
Risk

K900430 is an FDA 510(k) clearance for the IRRIGATION AND SUCTION APPARATUS. Classified as Apparatus, Suction, Ward Use, Portable, Ac-powered (product code JCX), Class II - Special Controls.

Submitted by Acorn Group, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on June 5, 1990 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Acorn Group, Inc. devices

Submission Details

510(k) Number K900430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1990
Decision Date June 05, 1990
Days to Decision 126 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 114d · This submission: 126d
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 75
Devices cleared under the same product code (JCX) and FDA review panel - the closest regulatory comparables to K900430.
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