Cleared Traditional

K161613 - Hang&Go PAC

K161613 is an FDA 510(k) clearance for Hang&Go PAC, manufactured by Rand S.R.L.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K161613 · Rand S.R.L. · General Hospital
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Dec 2016
Decision
201d
Days
Class 2
Risk

K161613 is an FDA 510(k) clearance for the Hang&Go PAC. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Rand S.R.L. (Medolla, IT). The FDA issued a Cleared decision on December 28, 2016 after a review of 201 days - an extended review cycle.

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 Rand S.R.L. devices

FDA 510(k) Submission Details - K161613

510(k) Number K161613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2016
Decision Date December 28, 2016
Days to Decision 201 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
72d slower than avg
Panel avg: 129d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGZ Device Classification - Class 2, Special Controls

Product Code LGZ Warmer, Thermal, Infusion Fluid
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 - LGZ Warmer, Thermal, Infusion Fluid

All 53
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K161613.
QiF Blood and Fluid Warmer
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QiF Blood and Fluid Warmer
K171215 · Quality IN Flow , Ltd. · Sep 2017
QiF Blood and Fluid Warmer
K163708 · Quality IN Flow , Ltd. · Apr 2017
QiF Blood and Fluid Warmer
K150404 · Quality IN Flow , Ltd. · Jun 2016
The Belmont Hyperthermia Pump
K152208 · Belmont Instrument Corporation · Sep 2015
Penguin In-Line Warmer
K150484 · Creche Innovations · Jul 2015