510(k) · Cleared
ClearedIrrigation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Corp. · ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Cleared on Apr 26, 1996 after a 31-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 480 devices in its family, counting itself, has a Class I recall. 479 later devices descend from it.
- Decided
- Apr 26, 1996
- Review
- 31 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 0
479 later devices descend from it, 1 citing it directly. 1 of the 480 devices in this family, counting this one, has a Class I recall.
- This deviceK961192 Irrigation SystemLinvatec Corp. · 1996
- Descendant · cites it directly · 478 of its ownK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- Descendant · 2 generations on · 477 of its ownK990524 E9000 SystemLinvatec Corp. · 1999
- Descendant · 3 generations on · 447 of its ownK012453 Sodem High Speed System (Electric) (General Orthopedics & Plastic…Sodemsystems · 2001
- Descendant · 3 generations on · 447 of its ownK012457 Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001
- Descendant · 3 generations on · 446 of its ownK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
Showing 5 of 479 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub10 generations on · 2021
Most influential descendants
Showing 5 of 479 · See all- K981637Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998 · cites it directly478descendants
- K990524E9000 SystemLinvatec Corp. · 1999 · 2 generations on477descendants
- K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems · 2001 · 3 generations on447descendants
- K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001 · 3 generations on447descendants
- K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001 · 3 generations on446descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961192 | Irrigation System | Linvatec Corp. | 1996 | — |
| +1 | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| +2 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| +3 | K012453 | Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) | Sodemsystems | 2001 | — |
| +3 | K012457 | Sodem High Speed System (Electric) (Neuro/Spine Surgery) | Sodemsystems | 2001 | — |
| +3 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 11 | 0 |
| 2017 | 16 | 0 |
| 2018 | 19 | 0 |
| 2019 | 27 | 0 |
| 2020 | 24 | 0 |
| 2021 | 45 | 1 |
| 2022 | 47 | 0 |
| 2023 | 64 | 0 |
| 2024 | 64 | 0 |
| 2025 | 67 | 0 |
| 2026 | 56 | 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.
1 device in this family has a Class I recall. 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 ERL device
- #1 K243280 Piezomed Pro (Piezomed Pro module M-PM100…score 12.0 · 9 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (479)
See all 4791 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K981637 | Integrated Drive/Pump System for Otolaryngology | 1998 | 478 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 10 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K981637 (Linvatec Corp., 1998) has gone furthest, with 478 descendants of its own.
How does its category compare?
All ERL devicesERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ERL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ERL
191in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ERL
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ERL
1,469in 2025
MAUDE reports naming product code ERL, 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 | 112 |
| 2008 | 6 | 181 | 0 | 60 |
| 2009 | 1 | — | 1 | 249 |
| 2010 | 0 | — | 0 | 444 |
| 2011 | 0 | — | 0 | 1,068 |
| 2012 | 2 | — | 0 | 1,379 |
| 2013 | 2 | — | 3 | 3,231 |
| 2014 | 1 | — | 0 | 1,975 |
| 2015 | 3 | 86 | 0 | 2,630 |
| 2016 | 4 | 180 | 0 | 1,455 |
| 2017 | 2 | — | 0 | 999 |
| 2018 | 1 | — | 0 | 1,380 |
| 2019 | 1 | — | 0 | 2,515 |
| 2020 | 1 | — | 5 | 2,369 |
| 2021 | 1 | — | 1 | 2,283 |
| 2022 | 3 | 191 | 0 | 1,574 |
| 2023 | 0 | — | 0 | 1,725 |
| 2024 | 1 | — | 0 | 1,588 |
| 2025 | 1 | — | 0 | 1,469 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K961192 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961192: 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/K961192
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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