Cleared Traditional

K010958 - FISTULOK FISTULA NEEDLE PROTECTION

K010958 is an FDA 510(k) clearance for FISTULOK FISTULA NEEDLE PROTECTION, manufactured by Diasol, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K010958 · Diasol, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
49d
Days
Class 2
Risk

K010958 is an FDA 510(k) clearance for the FISTULOK FISTULA NEEDLE PROTECTION. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Diasol, Inc. (North Hollywood, US). The FDA issued a Cleared decision on May 18, 2001 after a review of 49 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Diasol, Inc. devices

FDA 510(k) Submission Details - K010958

510(k) Number K010958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2001
Decision Date May 18, 2001
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 264
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K010958.
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K002938 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 2000
SIMPLICITY DISPOSABLE PEN NEEDLE
K002180 · Sterling Medivations, Inc. · Oct 2000