Cleared Traditional

K181667 - Thoraguard System (FDA 510(k) Clearance)

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

K181667 · Centese, Inc. · General & Plastic Surgery device
Nov 2018
Decision
157d
Days
Class 2
Risk

K181667 is an FDA 510(k) clearance for the Thoraguard System. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Centese, Inc. (Omaha, US). The FDA issued a Cleared decision on November 29, 2018 after a review of 157 days - an extended review 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: 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.

Submission Details

510(k) Number K181667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2018
Decision Date November 29, 2018
Days to Decision 157 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 132d · This submission: 157d
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 Peers - BTA Pump, Portable, Aspiration (manual Or Powered)

All 7
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K181667.
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
K260147 · Shenzhen Kingboom Technology Co., Ltd. · Mar 2026
Baby Nasal Aspirator (BN002)
K251450 · Shenzhen Desida Technology Co., Ltd. · Jun 2025
Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)
K244033 · Shenzhen Desida Technology Co., Ltd. · May 2025
AIRO Suction Unit (AIRO-01)
K251101 · Cro, LLC · Apr 2025
Electric Nasal Aspirator (BC026, BC025, BC023)
K250697 · Shenzhen Kingboom Technology Co., Ltd. · Apr 2025
Nasal Aspirator (NS 13)
K241852 · Avita Corporation · Dec 2024