Cleared Special

K011858 - INTERLINK THREADED LOCK CANNULA

K011858 is an FDA 510(k) clearance for INTERLINK THREADED LOCK CANNULA, manufactured by Bd. The device is a Class 2 General Hospital device with product code FPA cleared through the Special 510(k) pathway after a 5-day FDA review.

K011858 · Bd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
5d
Days
Class 2
Risk

K011858 is an FDA 510(k) clearance for the INTERLINK THREADED LOCK CANNULA. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Bd (Franklin Lakes, US). The FDA issued a Cleared decision on June 19, 2001 after a review of 5 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bd devices

FDA 510(k) Submission Details - K011858

510(k) Number K011858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2001
Decision Date June 19, 2001
Days to Decision 5 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
124d faster than avg
Panel avg: 129d · This submission: 5d
Pathway characteristics
Modification to existing cleared device.

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 533
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