Cleared Traditional

K230778 - EndoCore

K230778 is an FDA 510(k) clearance for EndoCore, manufactured by Praxis Medical, LLC. The device is a Class 2 Anesthesiology device with product code KTI cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K230778 · Praxis Medical, LLC · Anesthesiology device
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Sep 2023
Decision
188d
Days
Class 2
Risk

K230778 is an FDA 510(k) clearance for the EndoCore. Classified as Bronchoscope Accessory (product code KTI), Class II - Special Controls.

Submitted by Praxis Medical, LLC (Tampa, US). The FDA issued a Cleared decision on September 25, 2023 after a review of 188 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 874.4680 - 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 Praxis Medical, LLC devices

FDA 510(k) Submission Details - K230778

510(k) Number K230778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2023
Decision Date September 25, 2023
Days to Decision 188 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
48d slower than avg
Panel avg: 140d · This submission: 188d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTI Device Classification - Class 2, Special Controls

Product Code KTI Bronchoscope Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.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 Anesthesiology devices follow this clearance model.

Regulatory Consultant

Praxis Medical, LLC C/O Promedic, LLC
Paul Dryden

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.

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All 23
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