Cleared Traditional

K201203 - Cliq Aspirator

K201203 is the FDA 510(k) clearance for Cliq Aspirator by Anest Iwata Sparmax Co., Ltd.. It is a Class 2 General & Plastic Surgery device (product code BTA) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K201203 · Anest Iwata Sparmax Co., Ltd. · General & Plastic Surgery device
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Sep 2020
Decision
122d
Days
Class 2
Risk

K201203 is an FDA 510(k) clearance for the Cliq Aspirator. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Anest Iwata Sparmax Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on September 3, 2020 after a review of 122 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 Anest Iwata Sparmax Co., Ltd. devices

Submission Details

510(k) Number K201203 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2020
Decision Date September 03, 2020
Days to Decision 122 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 115d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTA Pump, Portable, Aspiration (manual Or 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 Consultant

Compliance Systems International, LLC
Robert O. Dean

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 42
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