510(k) · Cleared
ClearedSuperflow Irrigation and Aspiration Tubing Sets
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Armm, Inc. · KDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
Cleared on Jun 19, 1998 as substantially equivalent to K923201 (Armm, Inc., 1993) after a 72-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jun 19, 1998
- Review
- 72 days
- Class
- Class II
- Product code
- KDH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923201 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK923201 Endosi Suction IrrigatorArmm, Inc. · 1993
- This deviceK981286 Superflow Irrigation and Aspiration Tubing SetsArmm, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923201 | Endosi Suction Irrigator | Armm, Inc. | 1993 | — |
| 0 (this device) | K981286 | Superflow Irrigation and Aspiration Tubing Sets | Armm, Inc. | 1998 | — |
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 KDH? 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 |
|---|---|---|---|
| * | K923201 | Endosi Suction IrrigatorSummary page 1…Modification The devices listed in this 510(k) summary are modifications of the existing device called the EndoST Suction/Trrigator previously approved with the 510(K) #K923201. The safety and effectiveness of this device is substantially equivalent to that of the predicate device (The EndoSI Suction Irri… | 1993 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K923201.
How does its category compare?
All KDH devicesKDH Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KDH
FDA has decided no KDH device since 2007.
Median 510(k) review, days · KDH
Too few KDH 510(k)s in any year since 2007 to give a median.
Recalls per year · KDH
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KDH
3in 2022
MAUDE reports naming product code KDH, 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 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
T'he irrigation tubing scts will be used to flush and instill fluids into sites so that visibility is maintained for the operating team. The scts will be attached to standard irrigation systems such as either gravity bag systems attached to [.V. poles or to standard pump systems that use pressurized bottles instead of the gravity fed bags as the source of the irngant. The handle or accessory for irrigation would be attached to the end opposite the…
Read the full statement (141 words)
T'he irrigation tubing scts will be used to flush and instill fluids into sites so that visibility is maintained for the operating team. The scts will be attached to standard irrigation systems such as either gravity bag systems attached to [.V. poles or to standard pump systems that use pressurized bottles instead of the gravity fed bags as the source of the irngant. The handle or accessory for irrigation would be attached to the end opposite the irrigant source.
The aspiration tubing sets will be used for the removal of fluids, air or debris lefl after or during the surgery. These sets could be used just to remove the flushing irrigant that is used to keep the surgical arena visible. One end would be attached to the suction source and the other end would be attached to the suction tip handle.
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/K981286 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981286: Superflow Irrigation and Aspiration Tubing Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981286
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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