Cleared Traditional

K990208 - PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT

K990208 is an FDA 510(k) clearance for PERSONAL INFUSOR WITH DRUG DISPOSAL SEP..., manufactured by Science Incorporated. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K990208 · Science Incorporated · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
63d
Days
Class 2
Risk

K990208 is an FDA 510(k) clearance for the PERSONAL INFUSOR WITH DRUG DISPOSAL SEPTAL PORT. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Science Incorporated (Bloomington, US). The FDA issued a Cleared decision on March 25, 1999 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Science Incorporated devices

FDA 510(k) Submission Details - K990208

510(k) Number K990208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1999
Decision Date March 25, 1999
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - MEG Syringe, Antistick

All 48
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K990208.
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BECTON DICKINSON SYRINGE
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COVERTIP SAFETY SYRINGE
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EASYSAFE RETRACTING NEEDLE SYRINGE
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