510(k) · Cleared
ClearedBard Malecot and Pezzer Drains
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · FEW Catheter, Malecot
Cleared on Apr 24, 2007 as substantially equivalent to K910197 (C.R. Bard, Inc., 1991) and 1 other predicate after a 25-day review. Its family tree reaches back 1 generation to 1991. 2 later devices descend from it.
- Decided
- Apr 24, 2007
- Review
- 25 days
- Class
- Class II
- Product code
- FEW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910197 (1991). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK910197 Hydrogel-Coated Urethral Catheters and DrainsC.R. Bard, Inc. · 1991 · Recalled
- This deviceK070879 Bard Malecot and Pezzer DrainsC.R. Bard, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK101900 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910197 | Hydrogel-Coated Urethral Catheters and Drains | C.R. Bard, Inc. | 1991 | 1 |
| 0 (this device) | 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 | — |
| +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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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 FEW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K910197 | Hydrogel-Coated Urethral Catheters and DrainsSummary page 1…CFR Reference: 21 CFR 876.5090 C. Predicate Device Name: Trade Name(s): Bard malecot and pezzer drains (K910197 and K910846) D. Device Description: The drains are composed of a straight or angled, single lumen cathe… | 1991 |
| * | K910846 | Bard Latex Urinary Catheters Drains- Designs ModifSummary page 1…ference: 21 CFR 876.5090 C. Predicate Device Name: Trade Name(s): Bard malecot and pezzer drains (K910197 and K910846) D. Device Description: The drains are composed of a straight or angled, single lumen catheter shaft. T… | 1991 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K101900 (Hakki Medical Technologies, Inc., 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FEW devicesFEW Catheter, Malecot: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FEW
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FEW
Too few FEW 510(k)s in any year since 2007 to give a median.
Recalls per year · FEW
No recall names FEW since 2007.
Adverse event reports per year · FEW
1in 2023
MAUDE reports naming product code FEW, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Bard malecot and pezzer drains are intended for use in the drainage of urine. The drains are inserted suprapubically into the bladder or through a nephrostomy tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070879 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070879: Bard Malecot and Pezzer Drains.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070879
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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