Cleared Traditional

K162478 - ivWatch

K162478 is an FDA 510(k) clearance for ivWatch, manufactured by Ivwatch, LLC. The device is a Class 2 General Hospital device with product code PMS cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K162478 · Ivwatch, LLC · General Hospital
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Dec 2016
Decision
107d
Days
Class 2
Risk

K162478 is an FDA 510(k) clearance for the ivWatch. Classified as Peripheral Intravenous (piv) Infiltration Monitor (product code PMS), Class II - Special Controls.

Submitted by Ivwatch, LLC (Hampton, US). The FDA issued a Cleared decision on December 22, 2016 after a review of 107 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

FDA 510(k) Submission Details - K162478

510(k) Number K162478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2016
Decision Date December 22, 2016
Days to Decision 107 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
22d faster than avg
Panel avg: 129d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

PMS Device Classification - Class 2, Special Controls

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General Hospital devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02553421 Completed Interventional Industry-sponsored

Optical Detection of Intravenous Infiltration:A Pilot Study

243
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Infiltration of Peripheral IV Therapy
Study design Parallel
Eligibility All sexes
Sponsor ivWatch, LLC (industry)
Started 2015-08-01 → Primary completion 2016-07-01
Primary outcome
Time Infiltration Detected by Nurse
View full study on ClinicalTrials.gov