Cleared Traditional

K223729 - FLOWpresso (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K223729 · Medella Health Limited · Physical Medicine device
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Dec 2023
Decision
373d
Days
Class 2
Risk

K223729 is an FDA 510(k) clearance for the FLOWpresso. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Medella Health Limited (Tauranga, NZ). The FDA issued a Cleared decision on December 21, 2023 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Medella Health Limited devices

Submission Details

510(k) Number K223729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2022
Decision Date December 21, 2023
Days to Decision 373 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
258d slower than avg
Panel avg: 115d · This submission: 373d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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 Physical Medicine devices follow this clearance model.

Regulatory Consultant

Tilia Bridge
Samantha Nava

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 - IRP Massager, Powered Inflatable Tube

All 149
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