510(k) · Cleared
ClearedConmed Linvatec 24K Irrigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Linvatec · HRX Arthroscope
Cleared on Jan 31, 2007 as substantially equivalent to K033573 (Linvatec Corp., 2004) and 5 other predicates after an 89-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- Jan 31, 2007
- Review
- 89 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K950035 (1996). 18 ancestors in all, the oldest K852143 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK950035 Surgiflator 20W.O.M. GmbH · 1996
- 4 generations backK955791 Surgiflator-20 PimW.O.M. World of Medicine GmbH · 1996
- 3 generations backK981859 Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998
- 2 generations backK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- 1 generation backK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- This deviceK063326 Conmed Linvatec 24K Irrigation SystemConmed Linvatec · 2007
- Descendant · cites it directly · 0 of its ownK182882 CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable…Conmed Corporation · 2018
Most influential descendants
Showing 1 of 1 · See all- K182882CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote ControlConmed Corporation · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K950035 | Surgiflator 20 | W.O.M. GmbH | 1996 | — |
| −4 | K955791 | Surgiflator-20 Pim | W.O.M. World of Medicine GmbH | 1996 | — |
| −3 | K981859 | Surgiflator-20 Ecu | W.O.M. World of Medicine GmbH | 1998 | — |
| −2 | K990443 | Arthro-Surgimat-2000 Ecu | W.O.M. World of Medicine GmbH | 1999 | — |
| −1 | K030402 | Arthroscopy Pump, Model A107 | W.O.M. World of Medicine AG | 2003 | — |
| 0 (this device) | K063326 | Conmed Linvatec 24K Irrigation System | Conmed Linvatec | 2007 | — |
| +1 | 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 |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 |
|---|---|---|---|
| * | K033573 | Linvatec 10K Irrigation SystemSummary page 2…mmary 24k Irrigation System January 4, 2007 D. Predicate/Legally Marketed Devices 10k Irrigation System 510(k) # K033573 Linvatec Corporation 3M Fluid Irrigation System 510(k) #K941388 Linvatec Corporation (acquired from 3M H… | 2004 |
| * | K941388 | 3M Fluid Irrigation SystemSummary page 2…rrigation System 510(k) # K033573 Linvatec Corporation 3M Fluid Irrigation System 510(k) #K941388 Linvatec Corporation (acquired from 3M Healthcare) Nextra Arthroscopic Pump and Shaver System… | 1994 |
| * | K954465 | FMS DuoSummary page 2…510(k) #K941388 Linvatec Corporation (acquired from 3M Healthcare) Nextra Arthroscopic Pump and Shaver System 510(k) #K954465 Future Medical Systems, Inc. Arthroscopy Pump, Model A107 510(k) #K030402 W.O.M.… | 1995 |
| * | K030402 | Arthroscopy Pump, Model A107Summary page 2…stem 510(k) #K954465 Future Medical Systems, Inc. Arthroscopy Pump, Model A107 510(k) #K030402 W.O.M. World of Medicine, Ag Marketed by Stryker Endoscopy as FloControl Hall Irrigation System 510(… | 2003 |
| * | K961224 | Hydro-Flex LI Laparoscopic Irrigation SystemSummary page 2…510(k) # K852143 Linvatec Corporation (acquired from Hall Surgical) HydroFlex LI Laparoscopic Irrigation System 510(k) # K961224 Davol, Inc. E. Device Description The ConMed Linvatec 24k Irrigation System is a peristaltic pump system designed to automatica… | 1996 |
| * | K852143 | Hall Irrigation SystemSummary page 2…510(k) #K030402 W.O.M. World of Medicine, Ag Marketed by Stryker Endoscopy as FloControl Hall Irrigation System 510(k) # K852143 Linvatec Corporation (acquired from Hall Surgical) HydroFlex LI Laparoscopic Irrigation System… | 1985 |
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 |
|---|---|---|---|
| K182882 | CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control | 2018 | 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 11 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K182882 (Conmed Corporation, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 ConMed Linvatec 24k Irrigation System is a dual-head pump system
intended to provide fluid distention, irrigation, and suction during diagnostic and
operative knee, shoulder, hip, and small bone arthroscopic procedures and fluid
irrigation during laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063326 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063326: Conmed Linvatec 24K Irrigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063326
Report an extraction error
Are you the manufacturer?
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