Cleared Traditional

Renova RP Centesis Pump (K221042) - FDA 510(k) Clearance

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

K221042 · Gi Supply, Inc. · General & Plastic Surgery device
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Apr 2023
Decision
376d
Days
Class 2
Risk

K221042 is an FDA 510(k) clearance for the Renova RP Centesis Pump. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Gi Supply, Inc. (Mechanicsburg, US). The FDA issued a Cleared decision on April 19, 2023 after a review of 376 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Gi Supply, Inc. devices

Submission Details

510(k) Number K221042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2022
Decision Date April 19, 2023
Days to Decision 376 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
261d slower than avg
Panel avg: 115d · This submission: 376d
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 32
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K221042.
Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)
K233901 · Shenzhen Desida Technology Co., Ltd. · Mar 2024
Quiver Aspiration Pump
K232831 · Anoxia Medical, Inc. · Feb 2024
SOMAVAC® 100 Sustained Vacuum System
K231063 · Somavac Medical Solutions, Inc. · May 2023
Enivo™
K223373 · Aroa Biosurgery , Ltd. · Apr 2023
Geonic Nasal Aspirator, Geonic Nasal Cleaner
K220126 · Geon Corporation · Feb 2023
Electric nasal aspirator
K222547 · Shenzhen Xinlianfeng Technology Co.,Ltd · Oct 2022