Cleared Abbreviated

K153193 - Halo II Ambulatory Infusion System (als...

K153193 is an FDA 510(k) clearance for Halo II Ambulatory Infusion System (als..., manufactured by Zyno Medical, LLC. The device is a Class 2 General Hospital device with product code FRN cleared through the Abbreviated 510(k) pathway after a 301-day FDA review.

K153193 · Zyno Medical, LLC · General Hospital
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Aug 2016
Decision
301d
Days
Class 2
Risk

K153193 is an FDA 510(k) clearance for the Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulator.... Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Zyno Medical, LLC (Natick, US). The FDA issued a Cleared decision on August 30, 2016 after a review of 301 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Zyno Medical, LLC devices

FDA 510(k) Submission Details - K153193

510(k) Number K153193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2015
Decision Date August 30, 2016
Days to Decision 301 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
172d slower than avg
Panel avg: 129d · This submission: 301d
Pathway characteristics
Standards-based clearance path.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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.

Regulatory Peers - FRN Pump, Infusion

All 481
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