Cleared Special

K200629 - Aspire Mechanical Aspirator G

K200629 is the FDA 510(k) clearance for Aspire Mechanical Aspirator G by Control Medical Technology. It is a Class 2 General Hospital device (product code FMF) cleared through the Special 510(k) pathway after a 80-day FDA review.

K200629 · Control Medical Technology · General Hospital
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May 2020
Decision
80d
Days
Class 2
Risk

K200629 is an FDA 510(k) clearance for the Aspire Mechanical Aspirator G. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Control Medical Technology (Salt Lake City, US). The FDA issued a Cleared decision on May 29, 2020 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Control Medical Technology devices

Submission Details

510(k) Number K200629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2020
Decision Date May 29, 2020
Days to Decision 80 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 129d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 285
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