Cleared Traditional

K191290 - Ancora Nerve Block Catheter Set

K191290 is the FDA 510(k) clearance for Ancora Nerve Block Catheter Set by Ancora Medical Technology. It is a Class 2 Anesthesiology device (product code BSP) cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K191290 · Ancora Medical Technology · Anesthesiology device
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Feb 2020
Decision
269d
Days
Class 2
Risk

K191290 is an FDA 510(k) clearance for the Ancora Nerve Block Catheter Set. Classified as Needle, Conduction, Anesthetic (w/wo Introducer) (product code BSP), Class II - Special Controls.

Submitted by Ancora Medical Technology (Menlo Park, US). The FDA issued a Cleared decision on February 6, 2020 after a review of 269 days - an extended review cycle.

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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ancora Medical Technology devices

Submission Details

510(k) Number K191290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2019
Decision Date February 06, 2020
Days to Decision 269 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 140d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Decus Biomedical, Inc.
Terri Bogucki

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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

All 64
Devices cleared under the same product code (BSP) and FDA review panel - the closest regulatory comparables to K191290.
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