Cleared Traditional

K203135 - Medline Vacu-line Suction Aspirator (FDA 510(k) Clearance)

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

K203135 · Medline Industries, Inc. · General & Plastic Surgery device
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May 2021
Decision
197d
Days
Class 2
Risk

K203135 is an FDA 510(k) clearance for the Medline Vacu-line Suction Aspirator. Classified as Pump, Portable, Aspiration (manual Or Powered) (product code BTA), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on May 4, 2021 after a review of 197 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K203135 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2020
Decision Date May 04, 2021
Days to Decision 197 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
83d slower than avg
Panel avg: 114d · This submission: 197d
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 154
Devices cleared under the same product code (BTA) and FDA review panel - the closest regulatory comparables to K203135.
Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
K253107 · Shenzhen Dongjiang Technology Co., Ltd. · Apr 2026
Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)
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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