Cleared Traditional

K890398 - RYAN-STYLE DIRECTED INFUSION MANIPULATOR

K890398 is an FDA 510(k) clearance for RYAN-STYLE DIRECTED INFUSION MANIPULATOR, manufactured by Advanced Surgical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code HBI cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K890398 · Advanced Surgical Products, Inc. · General & Plastic Surgery device
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Feb 1989
Decision
24d
Days
Class 2
Risk

K890398 is an FDA 510(k) clearance for the RYAN-STYLE DIRECTED INFUSION MANIPULATOR. Classified as Illuminator, Fiberoptic, Surgical Field (product code HBI), Class II - Special Controls.

Submitted by Advanced Surgical Products, Inc. (Chesterfield, US). The FDA issued a Cleared decision on February 17, 1989 after a review of 24 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery 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 Advanced Surgical Products, Inc. devices

FDA 510(k) Submission Details - K890398

510(k) Number K890398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1989
Decision Date February 17, 1989
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBI Device Classification - Class 2, Special Controls

Product Code HBI Illuminator, Fiberoptic, Surgical Field
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - HBI Illuminator, Fiberoptic, Surgical Field

All 16
Devices cleared under the same product code (HBI) and FDA review panel - the closest regulatory comparables to K890398.
STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATOR
K904616 · Storz Instrument Co. · Apr 1991
XENON LIGHT SOURCE
K904609 · Medical Dynamics, Inc. · Dec 1990
STORZ FIBEROPTIC ENDO-ILLUMINATORS
K896549 · Storz Instrument Co. · Feb 1990
FIBEROPTIC BLUNT INTEGRAL PICK LIGHTPIPE
K883856 · Advanced Surgical Products, Inc. · Sep 1988
FIBEROPTIC WIRE PICK LIGHTPIPE
K883857 · Advanced Surgical Products, Inc. · Sep 1988
FIBEROPTIC SHARP INTEGRAL PICK LIGHTPIPE
K883858 · Advanced Surgical Products, Inc. · Sep 1988