510(k) · Cleared
Recalled · Class II · 2013Anspach Irrigation Pump and Irrigation Pump II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Anspach Effort, Inc. · FRN Pump, Infusion
Cleared on May 21, 2003 as substantially equivalent to K011444 (The Anspach Effort, Inc., 2001) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it. It has been recalled once.
- Decided
- May 21, 2003
- Review
- 86 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K852143 (1985). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK852143 Hall Irrigation SystemHall Surgical, Division of Zimmer, Inc. · 1985
- This deviceK030576 Anspach Irrigation Pump and Irrigation Pump IIThe Anspach Effort, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK061108 Stryker Auto Irrigation SystemStryker · 2007
- Descendant · cites it directly · 0 of its ownK063688 Surgical Irrigation System, Irrigation TubeThe Anspach Effort, Inc. · 2007
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 |
|---|---|---|---|---|---|
| −1 | K852143 | Hall Irrigation System | Hall Surgical, Division of Zimmer, Inc. | 1985 | — |
| 0 (this device) | K030576 | Anspach Irrigation Pump and Irrigation Pump II | The Anspach Effort, Inc. | 2003 | — |
| +1 | K061108 | Stryker Auto Irrigation System | Stryker | 2007 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 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 FRN? 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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 |
|---|---|---|---|
| * | K011444 | Anspach Emax Drill System | 2001 |
| * | K852143 | Hall Irrigation SystemSummary page 2…eristaltic pump used on the Anspach eMax Motor system (KO1 1444). The Irrigation system is substantially equivalent to the "Hall Ultrapower Irrigation Unit (Zimmer K852143), in that it is a peristaltic pump and control box, that is used with an irrigation tubing set and clip assembly. Materials… | 1985 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 3, 2013 | Class II | Z-1629-2014 | Mixed-up of materials/components | The Irrigation Clips were assembled with the incorrect (smaller) clips. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
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/K030576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030576: Anspach Irrigation Pump and Irrigation Pump II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030576
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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