Cleared Traditional

K262917 - Reprocessed BRK Transseptal Needle

K262917 is an FDA 510(k) clearance for Reprocessed BRK Transseptal Needle, manufactured by Innovative Health, LLC. The device is a Class 2 Cardiovascular device with product code NMK cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K262917 · Innovative Health, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
60d
Days
Class 2
Risk

K262917 is an FDA 510(k) clearance for the Reprocessed BRK Transseptal Needle. Classified as Trocar, Reprocessed (product code NMK), Class II - Special Controls.

Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on October 19, 2026 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1390 - the FDA cardiovascular device oversight 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.

FDA 510(k) Submission Details - K262917

510(k) Number K262917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2026
Decision Date October 19, 2026
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NMK Device Classification - Class 2, Special Controls

Product Code NMK Trocar, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1390
Definition Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
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 Cardiovascular devices follow this clearance model.

K262917 · Reprocessed BRK Transseptal Needle
Download PDF FDA Summary Innovative Health, LLC