Cleared Traditional

K001098 - PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01 (FDA 510(k) Clearance)

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

K001098 · Pro. Duct Health, Inc. · Pathology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
44d
Days
Class 2
Risk

K001098 is an FDA 510(k) clearance for the PRO.DUCT HEALTH MICRO-STYLET, MODEL STY01. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Pro. Duct Health, Inc. (Menlo Park, US). The FDA issued a Cleared decision on May 18, 2000 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 880.5570 - the FDA pathology 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 Pro. Duct Health, Inc. devices

Submission Details

510(k) Number K001098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2000
Decision Date May 18, 2000
Days to Decision 44 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 77d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Pathology devices follow this clearance model.

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