Cleared Traditional

K192998 - Reprocessed BRK Transseptal Needle

K192998 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 268-day FDA review.

K192998 · Innovative Health, LLC · Cardiovascular device
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Jul 2020
Decision
268d
Days
Class 2
Risk

K192998 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 July 22, 2020 after a review of 268 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Innovative Health, LLC devices

FDA 510(k) Submission Details - K192998

510(k) Number K192998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2019
Decision Date July 22, 2020
Days to Decision 268 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
143d slower than avg
Panel avg: 125d · This submission: 268d
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.