Cleared Traditional

Quiver Aspiration Pump (K232831) - FDA 510(k) Clearance

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

K232831 · Anoxia Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
162d
Days
Class 2
Risk

K232831 is an FDA 510(k) clearance for the Quiver Aspiration Pump. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Anoxia Medical, Inc. (Hayward, US). The FDA issued a Cleared decision on February 22, 2024 after a review of 162 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 Anoxia Medical, Inc. devices

Submission Details

510(k) Number K232831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2023
Decision Date February 22, 2024
Days to Decision 162 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
47d slower than avg
Panel avg: 115d · This submission: 162d
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

ProMedoss, Inc.
Bosmat Friedman-Cox

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 32
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K232831.
Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)
K242028 · Dongguanshi Yiyingmei Technology Co., Ltd. · Nov 2024
Electric nasal aspirator (HTD2601US)
K241202 · Hetaida Technology Co., Ltd. · Jul 2024
Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009)
K233901 · Shenzhen Desida Technology Co., Ltd. · Mar 2024
SOMAVAC® 100 Sustained Vacuum System
K231063 · Somavac Medical Solutions, Inc. · May 2023
Renova RP Centesis Pump
K221042 · Gi Supply, Inc. · Apr 2023
Enivo™
K223373 · Aroa Biosurgery , Ltd. · Apr 2023