Cleared Traditional

K192385 - ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable (FDA 510(k) Clearance)

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

K192385 · Ivwatch, LLC · General Hospital
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Jul 2020
Decision
303d
Days
Class 2
Risk

K192385 is an FDA 510(k) clearance for the ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, P.... Classified as Peripheral Intravenous (piv) Infiltration Monitor (product code PMS), Class II - Special Controls.

Submitted by Ivwatch, LLC (Newport News, US). The FDA issued a Cleared decision on July 2, 2020 after a review of 303 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ivwatch, LLC devices

Submission Details

510(k) Number K192385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2019
Decision Date July 02, 2020
Days to Decision 303 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 128d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PMS Peripheral Intravenous (piv) Infiltration Monitor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
Definition Peripheral Catheter Monitor (piv) Indicated For The Detection Of Subcutaneous Infiltrations And Extravasations.
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.