510(k) · Cleared
ClearedCabot Medical Niagara (TM) 3.0 Liter High Flow Irri
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cabot Medical Corp. · HET Laparoscope, Gynecologic (And Accessories)
Cleared on Feb 5, 1993 after a 150-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Feb 5, 1993
- Review
- 150 days
- Class
- Class II
- Product code
- HET
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK924530 Cabot Medical Niagara (TM) 3.0 Liter High Flow IrriCabot Medical Corp. · 1993
- Descendant · cites it directly · 5 of its ownK973133 Big Bag 3000 Pressure InfusorByron Medical · 1997
- Descendant · 2 generations on · 2 of its ownK980738 Psi-Tec Syringe Infusion Pump and Accessories for General Fluid…Byron Medical · 1998
- Descendant · 3 generations on · 1 of its ownK153599 Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC · 2016
- Descendant · cites it directly · 1 of its ownK980089 3600 Presure Infusor, Sigmacon 3600, Lapro Flow 3000Valley West, Inc. · 1998
- Descendant · 4 generations on · 0 of its ownK230083 SafiraMedovate Limited · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K973133Big Bag 3000 Pressure InfusorByron Medical · 1997 · cites it directly5descendants
- K980738Psi-Tec Syringe Infusion Pump and Accessories for General Fluid Irrigaion/InfiltrationByron Medical · 1998 · 2 generations on2descendants
- K153599Concert Medical Hands-Free Syringe (HFS)Concert Medical, LLC · 2016 · 3 generations on1descendant
- K9800893600 Presure Infusor, Sigmacon 3600, Lapro Flow 3000Valley West, Inc. · 1998 · cites it directly1descendant
- K230083SafiraMedovate Limited · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924530 | Cabot Medical Niagara (TM) 3.0 Liter High Flow Irri | Cabot Medical Corp. | 1993 | — |
| +1 | K973133 | Big Bag 3000 Pressure Infusor | Byron Medical | 1997 | — |
| +2 | K980738 | Psi-Tec Syringe Infusion Pump and Accessories for General Fluid… | Byron Medical | 1998 | — |
| +3 | K153599 | Concert Medical Hands-Free Syringe (HFS) | Concert Medical, LLC | 2016 | — |
| +1 | K980089 | 3600 Presure Infusor, Sigmacon 3600, Lapro Flow 3000 | Valley West, Inc. | 1998 | — |
| +4 | K230083 | Safira | Medovate Limited | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 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.
Planning a device in HET? 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 HET device
- #1 K250939 SIRIUS Endoscope System (PR-SI-1230)score 12.9 · 11 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K973133 (Byron Medical, 1997) has gone furthest, with 5 descendants of its own.
How does its category compare?
All HET devicesHET Laparoscope, Gynecologic (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HET
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HET
269in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HET
4in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HET
4,513in 2025
MAUDE reports naming product code HET, 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 | 181 |
| 2008 | 3 | 176 | 4 | 359 |
| 2009 | 1 | — | 1 | 403 |
| 2010 | 1 | — | 0 | 214 |
| 2011 | 2 | — | 0 | 417 |
| 2012 | 2 | — | 0 | 1,118 |
| 2013 | 2 | — | 0 | 1,035 |
| 2014 | 0 | — | 0 | 175 |
| 2015 | 2 | — | 1 | 124 |
| 2016 | 0 | — | 0 | 205 |
| 2017 | 2 | — | 0 | 89 |
| 2018 | 1 | — | 0 | 53 |
| 2019 | 2 | — | 0 | 44 |
| 2020 | 2 | — | 0 | 49 |
| 2021 | 4 | 269 | 0 | 132 |
| 2022 | 1 | — | 1 | 216 |
| 2023 | 0 | — | 4 | 824 |
| 2024 | 0 | — | 0 | 3,496 |
| 2025 | 2 | — | 0 | 4,513 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K924530 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924530: Cabot Medical Niagara (TM) 3.0 Liter High Flow Irri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924530
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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