Cleared Traditional

K133157 - TRI-OPTIC MEASUREMENT CELL

Also marketed or referenced as:
WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6

K133157 is an FDA 510(k) clearance for TRI-OPTIC MEASUREMENT CELL, manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code DRY cleared through the Traditional 510(k) pathway after a 371-day FDA review.

K133157 · Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
371d
Days
Class 2
Risk

K133157 is an FDA 510(k) clearance for the TRI-OPTIC MEASUREMENT CELL. Classified as Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (product code DRY), Class II - Special Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 23, 2014 after a review of 371 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Medtronic, Inc. devices

FDA 510(k) Submission Details - K133157

510(k) Number K133157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date October 23, 2014
Days to Decision 371 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
246d slower than avg
Panel avg: 125d · This submission: 371d
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 25
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