Cleared Traditional

K202154 - B-Capta

K202154 is an FDA 510(k) clearance for B-Capta, manufactured by Livanova Deutschland, GmbH. The device is a Class 2 Cardiovascular device with product code DRY cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K202154 · Livanova Deutschland, GmbH · Cardiovascular device
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Apr 2021
Decision
241d
Days
Class 2
Risk

K202154 is an FDA 510(k) clearance for the B-Capta. Classified as Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (product code DRY), Class II - Special Controls.

Submitted by Livanova Deutschland, GmbH (Munich, DE). The FDA issued a Cleared decision on April 1, 2021 after a review of 241 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4330 - 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 Livanova Deutschland, GmbH devices

FDA 510(k) Submission Details - K202154

510(k) Number K202154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2020
Decision Date April 01, 2021
Days to Decision 241 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
116d slower than avg
Panel avg: 125d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRY Device Classification - Class 2, Special Controls

Product Code DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4330
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 - DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

All 21
Devices cleared under the same product code (DRY) and FDA review panel - the closest regulatory comparables to K202154.
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