510(k) · Decided
DecidedBD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Cleared on May 29, 2026 as substantially equivalent to K910653 (C.R. Bard, Inc., 1991) after a 162-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- May 29, 2026
- Review
- 162 days
- Class
- Class II
- Product code
- FCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910653 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK910653 Touchless II Intermittent CatheterC.R. Bard, Inc. · 1991
- This deviceK254076 BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910653 | Touchless II Intermittent Catheter | C.R. Bard, Inc. | 1991 | — |
| 0 (this device) | K254076 | BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit | C.R. Bard, Inc. | 2026 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FCM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FCM device
- #1 K250891 Cure Catheter Insertion Kit (K1); Cure…score 10.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K910653 | Touchless II Intermittent CatheterSummary page 5…sion: Modified Device Predicate Device Trade Name: Bard Touchless II Intermittent Catheter tray Predicate 510(k) Number: K910653 Common Name(s): Rubber Utility Catheter, Urological Catheter, All-Purpose U… | 1991 |
| † | K223821 | Self-Cath Closed System | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All FCM devicesFCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FCM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FCM
Too few FCM 510(k)s in any year since 2007 to give a median.
Recalls per year · FCM
1in 2023
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FCM
35in 2025
MAUDE reports naming product code FCM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 6 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 31 | 4 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 5 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 0 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 61 |
| 2019 | 0 | — | 0 | 79 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 85 |
| 2022 | 0 | — | 6 | 59 |
| 2023 | 1 | — | 1 (1) | 48 |
| 2024 | 0 | — | 0 | 54 |
| 2025 | 1 | — | 0 | 35 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The BD Touchless™ Plus Unisex Urethral Catheter Kit is indicated for intermittent catheterization of the urethra to drain urine from the bladder by adult patients who are not capable of voluntary urination.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K254076 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254076: BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254076
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026