Cleared Traditional

K233881 - ivWatch® Model 400 (FDA 510(k) Clearance)

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

K233881 · Ivwatch, LLC · General Hospital
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Mar 2024
Decision
98d
Days
Class 2
Risk

K233881 is an FDA 510(k) clearance for the ivWatch® Model 400. 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 March 15, 2024 after a review of 98 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 K233881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2023
Decision Date March 15, 2024
Days to Decision 98 days
Submission Type Traditional
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
30d faster than avg
Panel avg: 128d · This submission: 98d
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.