Cleared Traditional

Aprima Smartesis Centesis Pump (K161002) - FDA 510(k) Clearance

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

K161002 · Cook Incorporated · General & Plastic Surgery device
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Sep 2016
Decision
170d
Days
Class 2
Risk

K161002 is an FDA 510(k) clearance for the Aprima Smartesis Centesis Pump. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on September 28, 2016 after a review of 170 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.

View all Cook Incorporated devices

Submission Details

510(k) Number K161002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2016
Decision Date September 28, 2016
Days to Decision 170 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
55d slower than avg
Panel avg: 115d · This submission: 170d
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 37
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K161002.
Thoraguard System
K181667 · Centese, Inc. · Nov 2018
SOMAVAC Device
K180606 · Somavac Medical Solutions, Inc. · May 2018
Rex Medical Aspiration Pump
K173389 · Rex Medical, L.P. · Jan 2018
PENUMBRA ASPIRATION PUMP, MODEL 115V
K051758 · Penumbra, Inc. · Aug 2005
UIMAT PUMP
K953132 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
COOK ASPIRATION/IRRIGATION UNIT
K944818 · Cook Urological, Inc. · Nov 1994