Cleared Traditional

K221319 - BD Alaris™ Pump Epidural Infusion Set (FDA 510(k) Clearance)

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

K221319 · Care Fusion · General Hospital
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Jul 2023
Decision
441d
Days
Class 2
Risk

K221319 is an FDA 510(k) clearance for the BD Alaris™ Pump Epidural Infusion Set. Classified as Administrations Sets With Neuraxial Connectors (product code PWH), Class II - Special Controls.

Submitted by Care Fusion (San Diego, US). The FDA issued a Cleared decision on July 21, 2023 after a review of 441 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.

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Submission Details

510(k) Number K221319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2022
Decision Date July 21, 2023
Days to Decision 441 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
313d slower than avg
Panel avg: 128d · This submission: 441d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PWH Administrations Sets With Neuraxial Connectors
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
Definition The Connector For Neuraxial Applications Is Intended To Facilitate Ansi/aami/iso 80369-6:2016 Compliant Neuraxial Specific Connections.
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.