Cleared Traditional

K161800 - OnSite-IV

K161800 is an FDA 510(k) clearance for OnSite-IV, manufactured by Pharmc, LLC. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K161800 · Pharmc, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
159d
Days
Class 2
Risk

K161800 is an FDA 510(k) clearance for the OnSite-IV. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Pharmc, LLC (Jackson, US). The FDA issued a Cleared decision on December 6, 2016 after a review of 159 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Pharmc, LLC devices

FDA 510(k) Submission Details - K161800

510(k) Number K161800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2016
Decision Date December 06, 2016
Days to Decision 159 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 129d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LHI Device Classification - Class 2, Special Controls

Product Code LHI Set, I.v. Fluid Transfer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - LHI Set, I.v. Fluid Transfer

All 79
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K161800.
Vial Adapter Ø20 mm
K190149 · Avenir Performance Europeenne Medical (Apem) · Oct 2019
nextaro Transfer System, nextaro va
K183187 · Sfm Medical Devices GmbH · Mar 2019
Guarded Luer Connector
K173577 · International Medical Industries, Inc. · Jun 2018
APEX Compounding System Transfer Set
K151423 · B.Braun Medical, Inc. · Feb 2016
Universal Spike
K150787 · B.Braun Medical, Inc. · Dec 2015
VIAL-MATE Adaptor
K142600 · Baxter Healthcare Corporation · Nov 2014