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Rusch IPN039319

by Teleflex Incorporated

Rusch IPN039319 (RLA-162-3C) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K010420 on 9 May 2001 and listed in FDA GUDID since 11 Jun 2019 (UDI-DI 14026704662002), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K010420

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number14026704662002 UDI-DI Date11 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK010420 Date9 May 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K010420 decided 9 May 2001 Active
  • FDA GUDID UDI-DI 14026704662002 listed 11 Jun 2019 Listed

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-0227-2023 FDA Class II initiated 20 Sep 2022

    Product may not be sterile

    • Terminated Z-0771-2017 FDA Class II initiated 22 Nov 2016

    Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life.

    • Terminated Z-1083-05 FDA Unclassified (pre-2012) initiated 11 Jul 2005 on shared 510(k) K010420

    There is a lack of assurance of sterility for parts of these lots of product.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K010420
  2. Recall initiated FDA recalls Z-1083-05
  3. Recall initiated FDA recalls Z-0771-2017
  4. Listed FDA GUDID 14026704662002
  5. Recall initiated FDA recalls Z-0227-2023

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Rusch
Generic name
Indwelling urethral drainage balloon catheter, non-antimicrobial
Model / Ref / Catalog
IPN039319, RLA-162-3C
Primary DI / UDI-DI
14026704662002
510(k) Number
FDA product code
KOD
GMDN term
Indwelling urethral drainage balloon catheter, non-antimicrobial
Device class
Class II
Regulation number
876.5130
GUDID distribution status
In Commercial Distribution
Size
Width — 6.5 Inch
Height — 0.5 Inch
Length — 11 Inch

Related devices

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Cleared under the same submission (K010420)

and 8 more cleared under K010420

Similar devices in this category

Other devices filed under Indwelling urethral drainage balloon catheter, non-antimicrobial.

Other devices from Teleflex Incorporated

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See all devices from Teleflex Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)