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Nelaton Female or Tiemann Catheter

by Unoplast A/S 510(k)

Active United States Open recall

510(k) K896729

Regulatory status

as of 29 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK896729 Date5 Nov 1990ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

14 recalls · 1 ongoing · FDA

    • Ongoing Z-1037-2019 FDA Class II initiated 9 Jan 2019

    An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

  • 13 recalls, same reason

    • Terminated Z-2942-2011 FDA Unclassified (pre-2012) initiated 30 Jun 2011
    • Terminated Z-2932-2011 FDA Unclassified (pre-2012) initiated 30 Jun 2011
    • Terminated Z-2933-2011 FDA Unclassified (pre-2012) initiated 30 Jun 2011
    • Terminated Z-2939-2011 FDA Unclassified (pre-2012) initiated 30 Jun 2011
    • Terminated Z-2934-2011 FDA Unclassified (pre-2012) initiated 30 Jun 2011
    • Terminated Z-2940-2011 FDA Unclassified (pre-2012) initiated 30 Jun 2011
    • Terminated Z-2937-2011 FDA Unclassified (pre-2012) initiated 30 Jun 2011
    • Terminated Z-2943-2011 FDA Unclassified (pre-2012) initiated 30 Jun 2011
    • Terminated Z-2936-2011 FDA Unclassified (pre-2012) initiated 30 Jun 2011
    • Terminated Z-2938-2011 FDA Unclassified (pre-2012) initiated 30 Jun 2011
    • Terminated Z-2941-2011 FDA Unclassified (pre-2012) initiated 30 Jun 2011
    • Terminated Z-2944-2011 FDA Unclassified (pre-2012) initiated 30 Jun 2011
    • Terminated Z-2935-2011 FDA Unclassified (pre-2012) initiated 30 Jun 2011

    Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.

Specification

510(k)

510(k) Number
FDA Product Code
KOD
Device Class
Class II
Regulation
21 CFR Part 876.5130
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Urological Catheter, specifically designed for urinary drainage. It features a Nelaton or Tiemann tip configuration, with the Tiemann variant incorporating a curved tip to facilitate navigation around anatomical obstructions, such as the prostate gland in male patients. The catheter is intended for intermittent or continuous drainage of urine from the bladder.

The Nelaton Female or Tiemann Catheter is supplied as a single-use, non-sterile device (unless sterilized by the user) and is typically made of PVC. It is available in multiple French sizes (6–24 Fr) and lengths, including a standard 40 cm version and a shorter 18 cm variant for female patients. The device is regulated under FDA 510(k) clearance (K896729) and falls under Class II medical device classification (KOD). No third-party review was required for this submission.

Other devices from Unoplast A/S

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the key differences between the Nelaton and Tiemann tips on this catheter, and how might they affect clinical use?

    The Nelaton tip is straight, making it suitable for general urinary drainage where minimal obstruction is expected. The Tiemann tip, however, features a curved design, which helps navigate anatomical challenges like the prostate gland in male patients. This curved tip may improve ease of insertion in cases where a straight catheter could encounter resistance.

  • Is this catheter intended for single-use only, and what material is it made from?

    Yes, this catheter is explicitly designed for single-use only. It is typically manufactured from PVC (polyvinyl chloride), which is a common material for urinary catheters due to its flexibility and durability. Since it is non-sterile as supplied, it must be sterilized by the user before use.

  • What sizes and lengths are available for this catheter, and how might they be selected for different patient needs?

    This catheter is available in multiple French sizes ranging from 6 Fr to 24 Fr, allowing for flexibility in patient needs based on bladder capacity, anatomical considerations, or clinical requirements. Lengths include a standard 40 cm version for general use and a shorter 18 cm variant specifically designed for female patients, where a shorter catheter reduces the risk of trauma or discomfort.

  • How should this catheter be stored, and are there any special handling instructions?

    Since the catheter is non-sterile as supplied, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its integrity. Before use, it must be sterilized by the healthcare provider using an appropriate method (e.g., autoclaving, chemical sterilization, or ethylene oxide). Always follow manufacturer guidelines for sterilization to ensure safety and effectiveness.

  • What regulatory pathway was followed for this device, and what does that mean for its use in clinical settings?

    This catheter was cleared via the FDA 510(k) pathway (K896729), meaning it was determined to be substantially equivalent to a legally marketed predicate device. It is classified as a Class II medical device under the KOD product code, which typically requires compliance with specific manufacturing controls and labeling requirements. While this does not imply direct FDA approval for specific clinical indications, it confirms the device meets regulatory standards for safety and performance as a urological catheter.