Cleared Traditional

Saalio (K191436) - FDA 510(k) Clearance

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

K191436 · Saalmann Medical GmbH & Co. KG · Physical Medicine device
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Oct 2019
Decision
141d
Days
Class 2
Risk

K191436 is an FDA 510(k) clearance for the Saalio. Classified as Device, Iontophoresis, Other Uses (product code EGJ), Class II - Special Controls.

Submitted by Saalmann Medical GmbH & Co. KG (Bad Oeynhausen, DE). The FDA issued a Cleared decision on October 18, 2019 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5525 - 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. Standard predicate reliance. 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 Saalmann Medical GmbH & Co. KG devices

Submission Details

510(k) Number K191436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2019
Decision Date October 18, 2019
Days to Decision 141 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
26d slower than avg
Panel avg: 115d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EGJ Device, Iontophoresis, Other Uses
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5525
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

Beo Medconsulting Berlin GmbH
Michael Vent

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 - EGJ Device, Iontophoresis, Other Uses

All 72
Devices cleared under the same product code (EGJ) and FDA review panel - the closest regulatory comparables to K191436.
STOPWET iontophoresis apparatus (SW01)
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Hidroxa SE30
K241267 · Hidroxa Medical AB · Oct 2024
Iontophoresis Electrodes
K232020 · Top-Rank Health Care Co., Ltd. · Oct 2023
Dermadry
K192749 · Dermadry Laboratories, Inc. · Feb 2020
Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE
K170835 · Hightech Development · Jun 2018
TULA Iontophoresis System with Earset
K150453 · Acclarent, Inc. · May 2015