Cleared Special

K222212 - ivWatch Model 400 (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K222212 · Ivwatch, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
30d
Days
Class 2
Risk

K222212 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 August 24, 2022 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ivwatch, LLC devices

Submission Details

510(k) Number K222212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2022
Decision Date August 24, 2022
Days to Decision 30 days
Submission Type Special
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
98d faster than avg
Panel avg: 128d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.