Cleared Traditional

K200893 - ProntoPump Sterile Tube Set

K200893 is an FDA 510(k) clearance for ProntoPump Sterile Tube Set, manufactured by Ipax, Inc.. The device is a Class 2 General Hospital device with product code LHI cleared through the Traditional 510(k) pathway after a 396-day FDA review.

K200893 · Ipax, Inc. · General Hospital
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May 2021
Decision
396d
Days
Class 2
Risk

K200893 is an FDA 510(k) clearance for the ProntoPump Sterile Tube Set. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Ipax, Inc. (Englewood, US). The FDA issued a Cleared decision on May 4, 2021 after a review of 396 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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. Elevated predicate reliance profile. 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 Ipax, Inc. devices

FDA 510(k) Submission Details - K200893

510(k) Number K200893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2020
Decision Date May 04, 2021
Days to Decision 396 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
267d slower than avg
Panel avg: 129d · This submission: 396d
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 74
Devices cleared under the same product code (LHI) and FDA review panel - the closest regulatory comparables to K200893.
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