Cleared Traditional

K202732 - SOL-CARE IV Bag Safety Connector (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202732 · Sol-Millennium Medical Group · General Hospital
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Nov 2021
Decision
411d
Days
Class 2
Risk

K202732 is an FDA 510(k) clearance for the SOL-CARE IV Bag Safety Connector. Classified as Set, I.v. Fluid Transfer (product code LHI), Class II - Special Controls.

Submitted by Sol-Millennium Medical Group (Suwanee, US). The FDA issued a Cleared decision on November 3, 2021 after a review of 411 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Sol-Millennium Medical Group devices

Submission Details

510(k) Number K202732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2020
Decision Date November 03, 2021
Days to Decision 411 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
283d slower than avg
Panel avg: 128d · This submission: 411d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 204
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