Cleared Traditional

K840919 - DAYPAK SYS VII CATHETER CARE KIT (FDA 510(k) Clearance)

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

K840919 · Creative Care Systems, Inc. · Anesthesiology device
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Apr 1984
Decision
47d
Days
Class 2
Risk

K840919 is an FDA 510(k) clearance for the DAYPAK SYS VII CATHETER CARE KIT. Classified as Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia (product code KLK), Class II - Special Controls.

Submitted by Creative Care Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2500 - the FDA anesthesiology and respiratory 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 Creative Care Systems, Inc. devices

Submission Details

510(k) Number K840919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1984
Decision Date April 17, 1984
Days to Decision 47 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 139d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2500
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 Anesthesiology devices follow this clearance model.