K170112 - IMD's Lumbar Puncture Needle (FDA 510(k) Clearance)

K170112 is an FDA 510(k) clearance for the IMD's Lumbar Puncture Needle. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by International Medical Development, Inc.(Imd) (Huntsville, US). The FDA issued a Cleared decision on February 2, 2018 after a review of 386 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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