Cleared Traditional

K240873 - TEMBO Embolic System

K240873 is an FDA 510(k) clearance for TEMBO Embolic System, manufactured by Instylla, Inc.. The device is a Class 2 Cardiovascular device with product code KRD cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K240873 · Instylla, Inc. · Cardiovascular device
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Dec 2024
Decision
262d
Days
Class 2
Risk

K240873 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 16, 2024 after a review of 262 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3300 - 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 Instylla, Inc. devices

FDA 510(k) Submission Details - K240873

510(k) Number K240873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2024
Decision Date December 16, 2024
Days to Decision 262 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
137d slower than avg
Panel avg: 125d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRD Device Classification - Class 2, Special Controls

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 97
Devices cleared under the same product code (KRD) and FDA review panel - the closest regulatory comparables to K240873.
Nitinol Enhanced Device (NED)
K250276 · Embolization, Inc. · May 2025
Ruby XL System
K250079 · Penumbra, Inc. · Mar 2025
Embozene Color-Advanced Microspheres
K242608 · Varian Medical Systems, Inc. · Jan 2025
ONCOZENE Microspheres
K242794 · Varian Medical Systems, Inc. · Oct 2024
OBSIDIO™ Conformable Embolic
K242507 · Boston Scientific · Oct 2024
Sunsphere
K232934 · Hangzhou Yangshun Medical Technology Co.,Ltd · May 2024