510(k) · Cleared
ClearedHakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 French
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 Feb 7, 2011 as substantially equivalent to K070879 (C.R. Bard, Inc., 2007) and 1 other predicate after a 215-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Feb 7, 2011
- Review
- 215 days
- Class
- Class II
- Product code
- GBM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K910197 (1991). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK910197 Hydrogel-Coated Urethral Catheters and DrainsC.R. Bard, Inc. · 1991 · Recalled
- 1 generation backK070879 Bard Malecot and Pezzer DrainsC.R. Bard, Inc. · 2007
- This deviceK101900 Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 FrenchHakki Medical Technologies, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK191512 LotusCatheter (Lotus No Balloon Catheter)Hakki Medical Technologies, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K191512LotusCatheter (Lotus No Balloon Catheter)Hakki Medical Technologies, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910197 | Hydrogel-Coated Urethral Catheters and Drains | C.R. Bard, Inc. | 1991 | 1 |
| −1 | K070879 | Bard Malecot and Pezzer Drains | C.R. Bard, Inc. | 2007 | — |
| 0 (this device) | K101900 | Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 French | Hakki Medical Technologies, Inc. | 2011 | — |
| +1 | 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 |
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? (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 |
|---|---|---|---|
| * | K070879 | Bard Malecot and Pezzer DrainsSummary page 1…The Hakki Urinary Catheter is substantially equivalent with respect to the following predicate devices: the Bard Malecot and Pezzer drains device (510(k) No. K070879) in terms of design, and the Bard Bardexl l.C. Latex Foley Catheter (510(k) No. K040658) in intended use. In… | 2007 |
| * | K040658 | Bardex I.C. Latex Foley CatheterSummary page 1…redicate devices: the Bard Malecot and Pezzer drains device (510(k) No. K070879) in terms of design, and the Bard Bardexl l.C. Latex Foley Catheter (510(k) No. K040658) in intended use. Intended use: The Hakki Urinary Catheter is used for contipuous drainage of fluid to and… | 2004 |
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 |
|---|---|---|---|
| K191512 | LotusCatheter (Lotus No Balloon Catheter) | 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 20 years and passes through 2 companies; a new generation was cleared every 15.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K191512 (Hakki Medical Technologies, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K070879.
How does its category compare?
All GBM devicesGBM Catheter, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Hakki Urinary Catheter is used for continuous drainage of fluid to and from the urethra. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder. it must be connected to a standard urinary collector.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101900: Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 French.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101900
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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