510(k) · Decided
DecidedLotusCatheter (Lotus No Balloon Catheter)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hakki Medical Technologies, Inc. · GBM Catheter, Urethral
Cleared on May 21, 2020 as substantially equivalent to K101900 (Hakki Medical Technologies, Inc., 2011) and 1 other predicate after a 349-day review. Its family tree reaches back 3 generations to 1991.
- Decided
- May 21, 2020
- Review
- 349 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K910197 (1991). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK910197 Hydrogel-Coated Urethral Catheters and DrainsC.R. Bard, Inc. · 1991 · Recalled
- 2 generations backK070879 Bard Malecot and Pezzer DrainsC.R. Bard, Inc. · 2007
- 1 generation backK101900 Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 FrenchHakki Medical Technologies, Inc. · 2011
- This deviceK191512 LotusCatheter (Lotus No Balloon Catheter)Hakki Medical Technologies, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910197 | Hydrogel-Coated Urethral Catheters and Drains | C.R. Bard, Inc. | 1991 | 1 |
| −2 | K070879 | Bard Malecot and Pezzer Drains | C.R. Bard, Inc. | 2007 | — |
| −1 | K101900 | Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 French | Hakki Medical Technologies, Inc. | 2011 | — |
| 0 (this device) | K191512 | LotusCatheter (Lotus No Balloon Catheter) | Hakki Medical Technologies, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2004 | 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? (2)
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 |
|---|---|---|---|
| * | K101900 | Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 FrenchSummary page 4…tract. dŚĞ>ŽƚƵƐEŽĂůůŽŽŶĂƚŚĞƚĞƌŝƐƚŽďĞƵƐĞĚŝŶƉĂƚŝĞŶƚƐ ϱLJĞĂƌƐŽĨĂŐĞŽƌŽůĚĞƌ͘ Predicate Device(s): K101900- Latex Hakki Urinary Catheter K070879- Latex Bard Malecot and Pezzer Drains Substantial Equiv… | 2011 |
| * | K070879 | Bard Malecot and Pezzer DrainsSummary page 4…ϱLJĞĂƌƐŽĨĂŐĞŽƌŽůĚĞƌ͘ Predicate Device(s): K101900- Latex Hakki Urinary Catheter K070879- Latex Bard Malecot and Pezzer Drains Substantial Equivalence: The Lotus No Balloon Catheter described in this 510(k)… | 2007 |
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?
- The line of descent spans 29 years and passes through 2 companies; a new generation was cleared every 9.3 years on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 LotusCatheter (Lotus No Balloon Catheter) is used for continuous drainage of fluid, including continuous bladder irrigation and intermittent catheterization. Drainage is generally accomplished by inserting the catheter through the urethra, suprapubically into the bladder or through a nephrostomy tract. The LotusCatheter (Lotus No Balloon Catheter) is to be used in patients 5 years of age or older.
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/K191512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191512: LotusCatheter (Lotus No Balloon Catheter).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191512
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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