510(k) · Cleared
Recalled · Class II · 2026Intermittent Catheter (Not Finalized)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hollister Incorporated · GBM Catheter, Urethral
Cleared on Jan 27, 2022 as substantially equivalent to K163179 (Hollister Incorporated, 2017) after a 262-day review. Its family tree reaches back 7 generations to 1991. It has been recalled once.
- Decided
- Jan 27, 2022
- Review
- 262 days
- Class
- Class II
- Product code
- GBM
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K910022 (1991). 15 ancestors in all, the oldest K896750 (1990). No later device cites it as a predicate yet.
- Root · 7 generations backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- 6 generations backK973070 Conveen Easicath SetColoplast Corp. · 1997
- 5 generations backK023254 SpeedicathColoplast Corp. · 2003
- 4 generations backK090960 Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142…Hollister, Inc. · 2009
- 3 generations backK110862 Vapro Plus Intermittent CatheterHollister Incorporated · 2011
- 2 generations backK141642 Vapro Intermittent CatheterHollister Incorporated · 2014
- 1 generation backK163179 Onli Intermittent CatheterHollister Incorporated · 2017
- This deviceK211436 Intermittent Catheter (Not Finalized)Hollister Incorporated · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| −6 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| −5 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| −4 | K090960 | Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064… | Hollister, Inc. | 2009 | — |
| −3 | K110862 | Vapro Plus Intermittent Catheter | Hollister Incorporated | 2011 | — |
| −2 | K141642 | Vapro Intermittent Catheter | Hollister Incorporated | 2014 | — |
| −1 | K163179 | Onli Intermittent Catheter | Hollister Incorporated | 2017 | — |
| 0 (this device) | K211436 | Intermittent Catheter (Not Finalized) | Hollister Incorporated | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
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 GBM? 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 GBM device
- #1 K241734 Wellead® Hydrophilic Intermittent Catheter…score 10.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K163179 | Onli Intermittent CatheterSummary page 4…e: Urological catheter and accessories Classification Number: 21 CFR 876.5130 Predicate Device: Onli Intermittent Catheter by Hollister Incorporated (K163179) The predicate device has not been subject to a design-related recall. Indications for Use: This intermittent catheter is a fl… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 14, 2026 | Class II | Z-2998-2026 | Process control | Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might lead to genitourinary trauma or bleeding. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 15 ancestors has a recall of any class.
- 1 other device also cites its predicate K163179.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · GBM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GBM
230in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GBM
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GBM
311in 2025
MAUDE reports naming product code GBM, 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 | 5 |
| 2008 | 0 | — | 5 | 18 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 2 | — | 1 | 46 |
| 2012 | 3 | 139 | 0 | 32 |
| 2013 | 0 | — | 0 | 41 |
| 2014 | 1 | — | 0 | 19 |
| 2015 | 5 | 76 | 0 | 21 |
| 2016 | 3 | 112 | 0 | 49 |
| 2017 | 2 | — | 0 | 59 |
| 2018 | 6 | 93 | 0 | 82 |
| 2019 | 7 | 121 | 0 | 148 |
| 2020 | 6 | 230 | 0 | 144 |
| 2021 | 0 | — | 0 | 102 |
| 2022 | 2 | — | 0 | 283 |
| 2023 | 0 | — | 1 (1) | 202 |
| 2024 | 0 | — | 0 | 468 |
| 2025 | 1 | — | 1 | 311 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211436 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211436: Intermittent Catheter (Not Finalized).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211436
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026