510(k) · Cleared
ClearedBard Laparoscopic Irrigator Pump System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davol, Inc. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Nov 16, 1990 after a 149-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Nov 16, 1990
- Review
- 149 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK902722 Bard Laparoscopic Irrigator Pump SystemDavol, Inc. · 1990
- Descendant · cites it directly · 3 of its ownK961224 Hydro-Flex LI Laparoscopic Irrigation SystemDavol Inc., Sub. C. R. Bard, Inc. · 1996
- Descendant · 2 generations on · 2 of its ownK033573 Linvatec 10K Irrigation SystemLinvatec Corp. · 2004
- Descendant · 2 generations on · 1 of its ownK063326 Conmed Linvatec 24K Irrigation SystemConmed Linvatec · 2007
- Descendant · 3 generations on · 0 of its ownK182882 CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable…Conmed Corporation · 2018
Most influential descendants
Showing 4 of 4 · See all- K961224Hydro-Flex LI Laparoscopic Irrigation SystemDavol Inc., Sub. C. R. Bard, Inc. · 1996 · cites it directly3descendants
- K033573Linvatec 10K Irrigation SystemLinvatec Corp. · 2004 · 2 generations on2descendants
- K063326Conmed Linvatec 24K Irrigation SystemConmed Linvatec · 2007 · 2 generations on1descendant
- K182882CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote ControlConmed Corporation · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K902722 | Bard Laparoscopic Irrigator Pump System | Davol, Inc. | 1990 | — |
| +1 | K961224 | Hydro-Flex LI Laparoscopic Irrigation System | Davol Inc., Sub. C. R. Bard, Inc. | 1996 | — |
| +2 | K033573 | Linvatec 10K Irrigation System | Linvatec Corp. | 2004 | — |
| +2 | K063326 | Conmed Linvatec 24K Irrigation System | Conmed Linvatec | 2007 | — |
| +3 | K182882 | CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control | Conmed Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K961224 | Hydro-Flex LI Laparoscopic Irrigation System | 1996 | 3 |
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?
- Of its descendants, K961224 (Davol Inc., Sub. C. R. Bard, Inc., 1996) has gone furthest, with 3 descendants of its own.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 0 | — | 0 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K902722 · printed Nov 6, 2026
Cite this page
510(k) Report. “K902722: Bard Laparoscopic Irrigator Pump System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902722
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026