# K972135: Maersk Medical Pureline Comfort Subcutaneous Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: P/L Biomedical
- Decided: Aug 26, 1997 after 81 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 8 cite it directly.
1 of 23 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K950018: Cambridge Heart CH 2000 Stress Test System, Cambridge Heart, Inc. (1996). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K032854: Unomedical Monica Infusion Set (2003), 14 descendants of its own
- K173879: MiniMed Mio Advance infusion set (2018), 3 descendants of its own
- K014062: Simplicity Easy Access Infusion Set (2002), 3 descendants of its own
- K061374: Intuition Infusion Sets (2006), 2 descendants of its own
- K041545: Contact Detach (2004), 2 descendants of its own

## Recalls of this device
- Nov 20, 2014 · Class II · Z-0885-2015: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached 
- Nov 20, 2014 · Class II · Z-0887-2015: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached 
- Nov 20, 2014 · Class II · Z-0884-2015: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached 
- Nov 20, 2014 · Class II · Z-0888-2015: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached 
- Nov 20, 2014 · Class II · Z-0891-2015: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached 
- Nov 20, 2014 · Class II · Z-0883-2015: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached 
- Nov 20, 2014 · Class II · Z-0886-2015: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached 
- Nov 20, 2014 · Class II · Z-0889-2015: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached 
- Nov 20, 2014 · Class II · Z-0890-2015: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached 
- Nov 20, 2014 · Class II · Z-0892-2015: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached 
- Nov 20, 2014 · Class II · Z-0893-2015: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached 
- Nov 20, 2014 · Class II · Z-0894-2015: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion set to become detached 
- Nov 7, 2014 · Class II · Z-0359-2017: Tubing detachment
- Nov 7, 2014 · Class II · Z-0357-2017: Tubing detachment
- Nov 7, 2014 · Class II · Z-0358-2017: Tubing detachment
- Nov 7, 2014 · Class II · Z-0355-2017: Tubing detachment

## Indications for use
The Subcutaneous Infusion Sets with indwelling Catheters are indicated for the infusion and/or injection of fluids into the body below the surface of the skin.

Source page: https://510kreport.com/device/K972135
Methodology: https://510kreport.com/methodology