Cleared Special

K121209 - TERUMO PALL AL20X ARTERIAL FILTER

K121209 is an FDA 510(k) clearance for TERUMO PALL AL20X ARTERIAL FILTER, manufactured by Terumo Cardiovascular Systems Corporation. The device is a Class 2 Cardiovascular device with product code DTM cleared through the Special 510(k) pathway after a 18-day FDA review.

K121209 · Terumo Cardiovascular Systems Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
18d
Days
Class 2
Risk

K121209 is an FDA 510(k) clearance for the TERUMO PALL AL20X ARTERIAL FILTER. Classified as Filter, Blood, Cardiopulmonary Bypass, Arterial Line (product code DTM), Class II - Special Controls.

Submitted by Terumo Cardiovascular Systems Corporation (Elkton, US). The FDA issued a Cleared decision on May 8, 2012 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4260 - 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.

FDA 510(k) Submission Details - K121209

510(k) Number K121209 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2012
Decision Date May 08, 2012
Days to Decision 18 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
107d faster than avg
Panel avg: 125d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

DTM Device Classification - Class 2, Special Controls

Product Code DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4260
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 - DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

All 95
Devices cleared under the same product code (DTM) and FDA review panel - the closest regulatory comparables to K121209.
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K121209 · TERUMO PALL AL20X ARTERIAL FILTER
Download PDF FDA Summary Terumo Cardiovascular…