510(k) · Cleared
ClearedSurgical Irrigation System, Irrigation Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Anspach Effort, Inc. · HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Cleared on Jan 16, 2007 as substantially equivalent to K030576 (The Anspach Effort, Inc., 2003) after a 35-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Jan 16, 2007
- Review
- 35 days
- Class
- Class I
- Product code
- HWE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K852143 (1985). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK852143 Hall Irrigation SystemHall Surgical, Division of Zimmer, Inc. · 1985
- 1 generation backK030576 Anspach Irrigation Pump and Irrigation Pump IIThe Anspach Effort, Inc. · 2003 · Recalled
- This deviceK063688 Surgical Irrigation System, Irrigation TubeThe Anspach Effort, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K852143 | Hall Irrigation System | Hall Surgical, Division of Zimmer, Inc. | 1985 | — |
| −1 | K030576 | Anspach Irrigation Pump and Irrigation Pump II | The Anspach Effort, Inc. | 2003 | 1 |
| 0 (this device) | K063688 | Surgical Irrigation System, Irrigation Tube | The Anspach Effort, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 HWE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K030576 | Anspach Irrigation Pump and Irrigation Pump IISummary page 1…General, Restorative and Neurological Devices 21 CFR § 878.4820 Predicate Surgical Irrigation System -> K030576 Devices Performance Standards There are no known standards established specifically for… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 2 companies; a new generation was cleared every 17.9 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K030576.
How does its category compare?
All HWE devicesHWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HWE
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HWE
Too few HWE 510(k)s in any year since 2007 to give a median.
Recalls per year · HWE
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWE
2,848in 2025
MAUDE reports naming product code HWE, 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 | 1 | — | 0 | 123 |
| 2008 | 0 | — | 0 | 72 |
| 2009 | 0 | — | 4 | 180 |
| 2010 | 0 | — | 2 | 297 |
| 2011 | 1 | — | 2 | 138 |
| 2012 | 0 | — | 0 | 221 |
| 2013 | 0 | — | 1 | 1,243 |
| 2014 | 0 | — | 3 | 3,794 |
| 2015 | 1 | — | 5 | 5,567 |
| 2016 | 0 | — | 2 | 4,974 |
| 2017 | 0 | — | 1 | 5,074 |
| 2018 | 0 | — | 0 | 3,589 |
| 2019 | 0 | — | 0 | 3,452 |
| 2020 | 0 | — | 0 | 3,248 |
| 2021 | 0 | — | 0 | 3,140 |
| 2022 | 0 | — | 0 | 3,327 |
| 2023 | 0 | — | 0 | 3,397 |
| 2024 | 0 | — | 0 | 3,686 |
| 2025 | 0 | — | 0 | 2,848 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Anspach Surgical Irrigation Systems are indicated for use with Anspach Surgical Motor Systems for providing controlled, cooling irrigation during cutting, shaping and removal of bone, including bones of the skull and spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063688 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063688: Surgical Irrigation System, Irrigation Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063688
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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