510(k) · Cleared
ClearedIntegrated Drive/Pump System for Otolaryngology
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 Jul 20, 1998 as substantially equivalent to K971059 (Linvatec Corp., 1997) and 5 other predicates after a 73-day review. Its family tree reaches back 3 generations to 1986. 1 of the 491 devices in its family, counting itself, has a Class I recall. 478 later devices descend from it.
- Decided
- Jul 20, 1998
- Review
- 73 days
- Class
- Class II
- Product code
- ERL
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K862807 (1986). 12 ancestors in all, the oldest K852143 (1985). 478 later devices descend from it, 1 citing it directly. 1 of the 491 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK862807 Treace Drill SystemTreace Medical, Inc. · 1986
- 2 generations backK964548 Apex Universal Drive SystemLinvatec Corp. · 1997
- 1 generation backK971059 Universal Drive SystemLinvatec Corp. · 1997
- This deviceK981637 Integrated Drive/Pump System for OtolaryngologyLinvatec Corp. · 1998
- Descendant · cites it directly · 477 of its ownK990524 E9000 SystemLinvatec Corp. · 1999
- Descendant · 2 generations on · 447 of its ownK012453 Sodem High Speed System (Electric) (General Orthopedics & Plastic…Sodemsystems · 2001
- Descendant · 2 generations on · 447 of its ownK012457 Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001
- Descendant · 2 generations on · 446 of its ownK012456 Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001
- Descendant · 3 generations on · 443 of its ownK081475 Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System…Medtronic Xomed, Inc. · 2008 · Recalled
Showing 5 of 478 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub9 generations on · 2021
Most influential descendants
Showing 5 of 478 · See all- K990524E9000 SystemLinvatec Corp. · 1999 · cites it directly477descendants
- K012453Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery)Sodemsystems · 2001 · 2 generations on447descendants
- K012457Sodem High Speed System (Electric) (Neuro/Spine Surgery)Sodemsystems · 2001 · 2 generations on447descendants
- K012456Sodem High Speed System (Electric) (Ear, Nose, and Throat)Sodemsystems · 2001 · 2 generations on446descendants
- K081475Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System, Integrated Power…Medtronic Xomed, Inc. · 2008 · 3 generations on443descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K862807 | Treace Drill System | Treace Medical, Inc. | 1986 | — |
| −2 | K964548 | Apex Universal Drive System | Linvatec Corp. | 1997 | — |
| −1 | K971059 | Universal Drive System | Linvatec Corp. | 1997 | — |
| 0 (this device) | K981637 | Integrated Drive/Pump System for Otolaryngology | Linvatec Corp. | 1998 | — |
| +1 | K990524 | E9000 System | Linvatec Corp. | 1999 | — |
| +2 | K012453 | Sodem High Speed System (Electric) (General Orthopedics & Plastic Surgery) | Sodemsystems | 2001 | — |
| +2 | K012457 | Sodem High Speed System (Electric) (Neuro/Spine Surgery) | Sodemsystems | 2001 | — |
| +2 | K012456 | Sodem High Speed System (Electric) (Ear, Nose, and Throat) | Sodemsystems | 2001 | — |
| +3 | K081475 | Electric Drill System [XPS 4000 System, Midas Rex Legend Ehs System… | Medtronic Xomed, Inc. | 2008 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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.
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? (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 |
|---|---|---|---|
| * | K971059 | Universal Drive SystemSummary page 4…H Linvatec System surgical procedures. v F PREDICATE |[Universal Drive To perform cutting of soft s Linvatec System tissue and bone in the s 510 (k) applications of : k #K971059 Arthroscopic/Orthopedic, Otolaryngological and g Reconstructive Surgery PREDICATE |Hall® Irrigation |General, Reconstructive - Li… | 1997 |
| * | K961192 | Irrigation SystemSummary page 4…hopedic, Otolaryngological and g Reconstructive Surgery PREDICATE |Hall® Irrigation |General, Reconstructive - Linvatec System surgery, and Otolaryngological |i 510 (k) #K961192 #K852143 PREDICATE |[TPS Total Resection of soft tissue and £ Stryker Performance bone in the applications of: [ Endoscopy |Syste… | 1996 |
| * | K852143 | Hall Irrigation SystemSummary page 4…Otolaryngological and g Reconstructive Surgery PREDICATE |Hall® Irrigation |General, Reconstructive - Linvatec System surgery, and Otolaryngological |i 510 (k) #K961192 #K852143 PREDICATE |[TPS Total Resection of soft tissue and £ Stryker Performance bone in the applications of: [ Endoscopy |System Spinal,… | 1985 |
| * | K943569 | Stryker Total Performance SystemSummary page 4…|[TPS Total Resection of soft tissue and £ Stryker Performance bone in the applications of: [ Endoscopy |System Spinal, Foot and Ankle, 510 (k) Plastics, ENT, and Neuro #K943569 . $K943589 ) . AND DISSIMILARITIES ystem consists of: Drive/Pump Console, High Speed Handpiece, igh Speed Drill,… | 1995 |
| * | K943589 | Stryker Total Performance SystemSummary page 4…Resection of soft tissue and £ Stryker Performance bone in the applications of: [ Endoscopy |System Spinal, Foot and Ankle, 510 (k) Plastics, ENT, and Neuro #K943569 . $K943589 ) . AND DISSIMILARITIES ystem consists of: Drive/Pump Console, High Speed Handpiece, igh Speed Drill, Cranial Pe… | 1994 |
| * | K952681 | Stryker Hummer II Microdebrider SystemSummary page 6…98 Page 5 of 5 CHART OF SIMILARITIES . Resection of soft tissue and . AR Ay s PREDICATE Stryker bone in the applications of: Endoscopy Head & Neck and ENT 510 (k) $#K952681 y AND DISSIMILARITIES : nha S e i sstem consists of: Drive/Pump Console, Handpiece, footswitch, itters, and Irri… | 1995 |
What descends from it? (478)
See all 4781 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990524 | E9000 System | 1999 | 477 |
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 · 9 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K990524 (Linvatec Corp., 1999) has gone furthest, with 477 descendants of its own.
- 10 other devices also cite its predicate K971059.
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 | — |
What is it indicated for?
The Integrated Drive/Pump System functions as a powered instrument system consisting of blades, burs, bur guards, associated handpieces, drive/pump console, footswitch, shaver adapter, and irrigation tubing sets to perform resection of soft tissue and Dbone. The field of application is Otolaryngology surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981637 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981637: Integrated Drive/Pump System for Otolaryngology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981637
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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