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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Medtech Consultants
SIGI CARON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LHI Set, I.v. Fluid Transfer

All 169
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K161800.
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