Cleared Traditional

K040636 - CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET

K040636 is an FDA 510(k) clearance for CADD ADMINISTRATION SET WITH FLOW STOP, manufactured by Smiths Medical MD, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K040636 · Smiths Medical MD, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
70d
Days
Class 2
Risk

K040636 is an FDA 510(k) clearance for the CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FL.... Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Smiths Medical MD, Inc. (St. Paul, US). The FDA issued a Cleared decision on May 19, 2004 after a review of 70 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smiths Medical MD, Inc. devices

FDA 510(k) Submission Details - K040636

510(k) Number K040636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2004
Decision Date May 19, 2004
Days to Decision 70 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
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 877
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