Cleared Traditional

K011888 - PRESSURE ACTIVATED CHECK VALVE

K011888 is an FDA 510(k) clearance for PRESSURE ACTIVATED CHECK VALVE, manufactured by Churchill Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K011888 · Churchill Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
84d
Days
Class 2
Risk

K011888 is an FDA 510(k) clearance for the PRESSURE ACTIVATED CHECK VALVE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Churchill Medical Systems, Inc. (Dover, US). The FDA issued a Cleared decision on September 10, 2001 after a review of 84 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 Churchill Medical Systems, Inc. devices

FDA 510(k) Submission Details - K011888

510(k) Number K011888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2001
Decision Date September 10, 2001
Days to Decision 84 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 129d · This submission: 84d
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 726
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