Cleared Traditional

K190070 - Sonopet iQ Ultrasonic Aspirator System

K190070 · Stryker Corporation · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Apr 2019
Decision
86d
Days
-
Risk

K190070 is an FDA 510(k) clearance for the Sonopet iQ Ultrasonic Aspirator System. Classified as Instrument, Ultrasonic Surgical (product code LFL).

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on April 11, 2019 after a review of 86 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Stryker Corporation devices

Submission Details

510(k) Number K190070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2019
Decision Date April 11, 2019
Days to Decision 86 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFL Instrument, Ultrasonic Surgical
Device Class -

Regulatory Peers - LFL Instrument, Ultrasonic Surgical

All 86
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