# K896729: Nelaton-, Female - or Tiemann Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Unoplast A/S
- Decided: Nov 5, 1990 after 340 days
- Product code: KOD (Catheter, Urological)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K033023: Intermittent Urethral Catheters (2003), 9 descendants of its own
- K072539: Cure Catheter (2007), 5 descendants of its own
- K110653: Cure Catheter (2011), 4 descendants of its own
- K132500: Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric, Cure Catheter Hydrophilic Coated (2013), 3 descendants of its own
- K111405: Bever Unocated / Coated, Paediatric / Male / Female Nelaton-Tip / Tiemann-Tip Intermittent Catheter, (2012), 2 descendants of its own

## Recalls of this device
- Jan 9, 2019 · Class II · Z-1037-2019: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.
- Jun 30, 2011 · Not classified · Z-2934-2011: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
- Jun 30, 2011 · Not classified · Z-2942-2011: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
- Jun 30, 2011 · Not classified · Z-2944-2011: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
- Jun 30, 2011 · Not classified · Z-2941-2011: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
- Jun 30, 2011 · Not classified · Z-2938-2011: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
- Jun 30, 2011 · Not classified · Z-2940-2011: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
- Jun 30, 2011 · Not classified · Z-2935-2011: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
- Jun 30, 2011 · Not classified · Z-2936-2011: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
- Jun 30, 2011 · Not classified · Z-2943-2011: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
- Jun 30, 2011 · Not classified · Z-2939-2011: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
- Jun 30, 2011 · Not classified · Z-2932-2011: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
- Jun 30, 2011 · Not classified · Z-2937-2011: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
- Jun 30, 2011 · Not classified · Z-2933-2011: Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.

Source page: https://510kreport.com/device/K896729
Methodology: https://510kreport.com/methodology