Cleared Traditional

K101194 - NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR...

K101194 is an FDA 510(k) clearance for NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR..., manufactured by Carticept Medical, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 439-day FDA review.

K101194 · Carticept Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
439d
Days
Class 2
Risk

K101194 is an FDA 510(k) clearance for the NAVIGATOR DELIVERY SYSTEM (OR NAVIGATOR DS) MODEL: NAV-010. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Carticept Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on July 11, 2011 after a review of 439 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 Carticept Medical, Inc. devices

FDA 510(k) Submission Details - K101194

510(k) Number K101194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2010
Decision Date July 11, 2011
Days to Decision 439 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
310d slower than avg
Panel avg: 129d · This submission: 439d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 481
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