510(k) · Cleared
ClearedSI Controller Model SI 500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I.C Medical, Inc. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Dec 23, 1996 as substantially equivalent to K932230 (I.C Medical, Inc., 1994) and 1 other predicate after a 325-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Dec 23, 1996
- Review
- 325 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932230 (1994). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK932230 Crystal Vision and AccessoriesI.C Medical, Inc. · 1994
- This deviceK960492 SI Controller Model SI 500I.C Medical, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932230 | Crystal Vision and Accessories | I.C Medical, Inc. | 1994 | — |
| 0 (this device) | K960492 | SI Controller Model SI 500 | I.C Medical, Inc. | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 BTA? 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 BTA device
- #1 K222547 Electric nasal aspiratorscore 20.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K932230 | Crystal Vision and AccessoriesSummary page 1…Cabot Medical, Cabot Irrigation Pump; Nezhat-Dorsey Hydro-Dissection System; Bard/DavelEndo-FleJrrigation-§ Tubing Sets: I.C. Medical Sterile Disposable Tubing Set (p/o K932230) I.C. Medical PenEvac SI (K955166) Description of the Suction/Irrigation Controller: The SI Controller Model SIS00 controls the… | 1994 |
| * | K955166 | Penevac SI. Cleared while this submission was under review Summary page 1…mp; Nezhat-Dorsey Hydro-Dissection System; Bard/DavelEndo-FleJrrigation-§ Tubing Sets: I.C. Medical Sterile Disposable Tubing Set (p/o K932230) I.C. Medical PenEvac SI (K955166) Description of the Suction/Irrigation Controller: The SI Controller Model SIS00 controls the flow of fluids and vacuum to suct… | 1996 |
| * | — | Cabot Medical, Cabot Irrigation Pump Named without a submission number | |
| * | — | Nezhat-Dorsey Hydro-Dissection System Named without a submission number | |
| * | — | Bard/DavelEndo-FleJrrigation-§ Named without a submission number |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K932230.
How does its category compare?
All BTA devicesBTA Pump, Portable, Aspiration (Manual Or Powered): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTA
7so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · BTA
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTA
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTA
13in 2025
MAUDE reports naming product code BTA, 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 | — | 1 | 13 |
| 2008 | 3 | 135 | 3 | 5 |
| 2009 | 2 | — | 0 | 14 |
| 2010 | 2 | — | 3 | 178 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 3 | 45 | 0 | 18 |
| 2014 | 3 | 91 | 0 | 399 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 3 | 149 | 0 | 25 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 4 | 125 | 0 | 17 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 10 |
| 2021 | 1 | — | 1 | 9 |
| 2022 | 3 | 58 | 0 | 7 |
| 2023 | 4 | 265 | 0 | 8 |
| 2024 | 5 | 131 | 0 | 13 |
| 2025 | 6 | 87 | 0 | 13 |
| 2026 | 7 | 89 | 0 | — |
What is it indicated for?
The I.C. Medical SI Controller Model SI 500 is intended to be used to control the flow of irrigation fluids and vacuum to suction/irrigation and multifunction accessories having compatible suction/irrigation features during wound-eare-and-_open and closed surgical procedures. When used with appropriate accessories the SI Controller may be used for hydro-dissection.
The SI Controller is not intended for use in delivering any blood or blood products
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/K960492 · printed Nov 5, 2026
Cite this page
510(k) Report. “K960492: SI Controller Model SI 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K960492
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