510(k) · Cleared
ClearedActreen Hi-Lite Cath, Actreen Hi-Lite Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · GBM Catheter, Urethral
Cleared on Nov 5, 2018 as substantially equivalent to K151772 (B.Braun Medical, Inc., 2016) after a 222-day review. Its family tree reaches back 6 generations to 1991. 1 later device descends from it.
- Decided
- Nov 5, 2018
- Review
- 222 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K910022 (1991). 8 ancestors in all, the oldest K896750 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK910022 MMG/O'neil Urinary Catheterization System KitMedical Marketing Group · 1991
- 5 generations backK973070 Conveen Easicath SetColoplast Corp. · 1997
- 4 generations backK023254 SpeedicathColoplast Corp. · 2003
- 3 generations backK072808 Speedicath CompactColoplast Corp. · 2007
- 2 generations backK121457 Speedicath Compact Set (12 FR)Coloplast Corp. · 2012
- 1 generation backK151772 Actreen Mini Intermittent Urinary CathetersB.Braun Medical, Inc. · 2016
- This deviceK180801 Actreen Hi-Lite Cath, Actreen Hi-Lite SetB.Braun Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK192577 Actreen Hi-Lite Intermittent Urinary CathetersB.Braun Medical, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K192577Actreen Hi-Lite Intermittent Urinary CathetersB.Braun Medical, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K910022 | MMG/O'neil Urinary Catheterization System Kit | Medical Marketing Group | 1991 | — |
| −5 | K973070 | Conveen Easicath Set | Coloplast Corp. | 1997 | — |
| −4 | K023254 | Speedicath | Coloplast Corp. | 2003 | — |
| −3 | K072808 | Speedicath Compact | Coloplast Corp. | 2007 | — |
| −2 | K121457 | Speedicath Compact Set (12 FR) | Coloplast Corp. | 2012 | — |
| −1 | K151772 | Actreen Mini Intermittent Urinary Catheters | B.Braun Medical, Inc. | 2016 | — |
| 0 (this device) | K180801 | Actreen Hi-Lite Cath, Actreen Hi-Lite Set | B.Braun Medical, Inc. | 2018 | — |
| +1 | K192577 | Actreen Hi-Lite Intermittent Urinary Catheters | B.Braun Medical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 |
|---|---|---|---|
| * | K151772 | Actreen Mini Intermittent Urinary CathetersSummary page 4…Urological Catheter and Accessories Classification Product Code: GBM PREDICATE DEVICE: 510(k) Number: K151772 Device Name: Actreen® Mini Intermittent Urinary Catheters C… | 2016 |
| † | K141642 | Vapro Intermittent Catheter | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192577 | Actreen Hi-Lite Intermittent Urinary Catheters | 2020 | 0 |
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K192577 (B.Braun Medical, Inc., 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Actreen® Hi-Lite Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by adult and pediatric patients with chronic urine retention or voiding dysfunction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180801 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180801: Actreen Hi-Lite Cath, Actreen Hi-Lite Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180801
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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