# K071253: Affinity Pediatric Arterial Filter, Model S4014 and with Carmeda Bioactive Surface, Model CB4014

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Jul 3, 2007 after 60 days
- Product code: DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line)
- Device class: 2
- Regulation: 21 CFR 870.4260
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943917 (1995). 3 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943917: Capiox Arterial Filter, Terumo Medical Corp. (1995) Summary page 1.
- K952532: Affinity Arterial Blood Filter, Avecor Cardiovascular, Inc. (1995) Summary page 1.
- K000379: Modofication to Afffinity 38 Micro Arterial Blood Filter with Carmeda Bioactive Surface, Models CB351/CB352, Medtronic Vascular (2000) Summary page 1.

## Most influential descendants
- K111972: Affinity CP Centrifugal Pump, Resting Heart Sys.,Myotherm Cardioplegia Deliv.,Affinity Hollow Fiber Oxygenator,Aaf (2011), 5 descendants of its own
- K120988: DLP Single Stage Venous Cannula, DLP Right Angle Single Stage Venous Cannula, DLP Single Stage Venous Cannula with Right (2012), 4 descendants of its own
- K140165: MC2 Two-Stage Venous Cannula, Oval MC2 Two-Stage Venous Cannula, Thin Wall Two-Stage Venous Cannula, MC2X Three-Stage VE (2014), 2 descendants of its own
- K251258: MC2™ Two-Stage Venous Cannula; MC2X™ Three-Stage Venous Cannula (2025), 1 descendant of its own
- K262052: Tri Stage Venous Cannulae (2026), 0 descendants of its own

## Recalls of this device
- Jun 14, 2013 · Class II · Z-1966-2013: Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the filter media that may allow unwanted parti
- May 9, 2008 · Not classified · Z-1921-2008: Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin.

## Indications for use
AFFINITY® Pediatric Arterial Filter is indicated for use in cardiopulmonary bypass procedures up to 6 hours in duration for the removal of particulate and gaseous microemboli.

Source page: https://510kreport.com/device/K071253
Methodology: https://510kreport.com/methodology