Cleared Special

K253677 - Tembo Embolic System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K253677 · Instylla, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Dec 2025
Decision
24d
Days
Class 2
Risk

K253677 is an FDA 510(k) clearance for the Tembo Embolic System. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by Instylla, Inc. (Bedford, US). The FDA issued a Cleared decision on December 15, 2025 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Instylla, Inc. devices

Submission Details

510(k) Number K253677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2025
Decision Date December 15, 2025
Days to Decision 24 days
Submission Type Special
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
101d faster than avg
Panel avg: 125d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
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.

Regulatory Peers - KRD Device, Vascular, For Promoting Embolization

All 127
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K253677.
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K253511 · Medtronic, Inc. · Jan 2026
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K253376 · Boston Scientific Corporation · Oct 2025
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K250209 · Canyon Medical, Inc. · Sep 2025
HARBOR Occlusion Device
K250133 · Nuvascular, Inc. · Jul 2025
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K251383 · Balt USA, LLC · May 2025