510(k) · Cleared
ClearedLinvatec 10K Irrigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · HRX Arthroscope
Cleared on Feb 11, 2004 as substantially equivalent to K961590 (Linvatec Corp., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1990. 2 later devices descend from it.
- Decided
- Feb 11, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K902722 (1990). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK902722 Bard Laparoscopic Irrigator Pump SystemDavol, Inc. · 1990
- 1 generation backK961224 Hydro-Flex LI Laparoscopic Irrigation SystemDavol Inc., Sub. C. R. Bard, Inc. · 1996
- This deviceK033573 Linvatec 10K Irrigation SystemLinvatec Corp. · 2004
- Descendant · cites it directly · 1 of its ownK063326 Conmed Linvatec 24K Irrigation SystemConmed Linvatec · 2007
- Descendant · 2 generations on · 0 of its ownK182882 CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable…Conmed Corporation · 2018
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 |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | K033573 | Linvatec 10K Irrigation System | Linvatec Corp. | 2004 | — |
| +1 | K063326 | Conmed Linvatec 24K Irrigation System | Conmed Linvatec | 2007 | — |
| +2 | K182882 | CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control | Conmed Corporation | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2018 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 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? (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 |
|---|---|---|---|
| * | K961590 | Apex Universal Irrigation System & Two-Connection Tubing SetSummary page 2…Safety and Effectiveness 10K Irrigation System 510(k) # November 03, 2003 D. Predicate/Legally Marketed Devices Apex Universal Irrigation System 510(k) # K961590 Linvatec Corporation Hydro-Flex Li Laparoscopic Irrigation System: 510(K) # K961224 Davol Incorporated… | 1996 |
| * | K961224 | Hydro-Flex LI Laparoscopic Irrigation SystemSummary page 2…eted Devices Apex Universal Irrigation System 510(k) # K961590 Linvatec Corporation Hydro-Flex Li Laparoscopic Irrigation System: 510(K) # K961224 Davol Incorporated E. Device Description The Linvatec 10k Irrigation System is a peristaltic, microprocessor… | 1996 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063326 | Conmed Linvatec 24K Irrigation System | 2007 | 1 |
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 14 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K063326 (Conmed Linvatec, 2007) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The Linvatec 10k Irrigation System provides controlled fluid distension and irrigation to the operative site during arthroscopic and laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033573 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033573: Linvatec 10K Irrigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033573
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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