Cleared Traditional

K121812 - SONIXGPS

K121812 is an FDA 510(k) clearance for SONIXGPS, manufactured by Ultrasonix Medical Corporation. The device is a Class 2 Anesthesiology device with product code BSP cleared through the Traditional 510(k) pathway after a 530-day FDA review.

K121812 · Ultrasonix Medical Corporation · Anesthesiology device
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Dec 2013
Decision
530d
Days
Class 2
Risk

K121812 is an FDA 510(k) clearance for the SONIXGPS. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Ultrasonix Medical Corporation (Monroe, US). The FDA issued a Cleared decision on December 2, 2013 after a review of 530 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5150 - the FDA anesthesiology and respiratory 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Ultrasonix Medical Corporation devices

FDA 510(k) Submission Details - K121812

510(k) Number K121812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2012
Decision Date December 02, 2013
Days to Decision 530 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
390d slower than avg
Panel avg: 140d · This submission: 530d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSP Device Classification - Class 2, Special Controls

Product Code BSP Needle, Conduction, Anesthetic (w/wo Introducer)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5150
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BSP Needle, Conduction, Anesthetic (w/wo Introducer)

All 85
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