510(k) · Cleared
ClearedIrrigation or Infusion Pump K Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kmi Kolster Methods, Inc. · FRN Pump, Infusion
Cleared on Oct 15, 1999 after a 190-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 29 devices in its family, counting itself, have a Class I recall. 28 later devices descend from it.
- Decided
- Oct 15, 1999
- Review
- 190 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 2 citing it directly. 2 of the 29 devices in this family, counting this one, have a Class I recall.
- This deviceK991203 Irrigation or Infusion Pump K PumpKmi Kolster Methods, Inc. · 1999
- Descendant · cites it directly · 26 of its ownK071328 Visualase Thermal Therapy SystemBiotex, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 22 of its ownK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
- Descendant · 3 generations on · 21 of its ownK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 19 of its ownK131955 Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 19 of its ownK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 28 · See all- K071328Visualase Thermal Therapy SystemBiotex, Inc. · 2007 · cites it directly26descendants
- K081509Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009 · 2 generations on22descendants
- K120561Neuroblate SystemMonteris Medical, Inc. · 2013 · 3 generations on21descendants
- K131955Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · 4 generations on19descendants
- K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · 4 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991203 | Irrigation or Infusion Pump K Pump | Kmi Kolster Methods, Inc. | 1999 | — |
| +1 | K071328 | Visualase Thermal Therapy System | Biotex, Inc. | 2007 | 1 |
| +2 | K081509 | Monteris Medical Autolitt Laser Probe | Monteris Medical, | 2009 | — |
| +3 | K120561 | Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| +4 | K131955 | Neuroblate (TM) System | Monteris Medical, Inc. | 2013 | 2 |
| +4 | K131278 | Monteris Medical Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 4 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (28)
See all 282 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K071328 (Biotex, Inc., 2007) has gone furthest, with 26 descendants of its own.
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?
The KM I Irrigation or Infusion pump “K” Pump is intended for the administration of sterile solutions drawn from containers using standard sterile administration sets with a 3/8 diameter silicone peristaltic section. The “K” Pump is intended for the rapid introduction of sterile fluids into the wound site for wound irrigation. The “K” pump may also be used with K.M.L.’s DIK Irrigation System.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991203 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991203: Irrigation or Infusion Pump K Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991203
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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