510(k) · Cleared
ClearedKlein Surgical Infiltration Pump, Model Kip-II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hk Surgical, Inc. · FRN Pump, Infusion
Cleared on Aug 7, 2003 after a 93-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Aug 7, 2003
- Review
- 93 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK031432 Klein Surgical Infiltration Pump, Model Kip-IIHk Surgical, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK170629 Vitruvian Infiltration PumpBlack & Black Surgical, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK123822 Klein Touch Pump and Disposable Tubing SetHk Surgical, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK220318 PAL Infiltration SystemMicroaire Surgical Instruments, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK151255 Navigator Aesthetic Delivery SystemCarticept Medical, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK050324 Infpump Infiltration PumpCarolina Medical, Inc. · 2005
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K170629Vitruvian Infiltration PumpBlack & Black Surgical, Inc. · 2017 · cites it directly1descendant
- K123822Klein Touch Pump and Disposable Tubing SetHk Surgical, Inc. · 2013 · cites it directly1descendant
- K220318PAL Infiltration SystemMicroaire Surgical Instruments, LLC · 2022 · 2 generations on0descendants
- K151255Navigator Aesthetic Delivery SystemCarticept Medical, Inc. · 2015 · 2 generations on0descendants
- K050324Infpump Infiltration PumpCarolina Medical, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031432 | Klein Surgical Infiltration Pump, Model Kip-II | Hk Surgical, Inc. | 2003 | — |
| +1 | K170629 | Vitruvian Infiltration Pump | Black & Black Surgical, Inc. | 2017 | — |
| +1 | K123822 | Klein Touch Pump and Disposable Tubing Set | Hk Surgical, Inc. | 2013 | — |
| +2 | K220318 | PAL Infiltration System | Microaire Surgical Instruments, LLC | 2022 | — |
| +2 | K151255 | Navigator Aesthetic Delivery System | Carticept Medical, Inc. | 2015 | — |
| +1 | K050324 | Infpump Infiltration Pump | Carolina Medical, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 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.
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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
4 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, K170629 (Black & Black Surgical, Inc., 2017) has gone furthest, with 1 descendant 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?
This Infiltration Pump is used to cause a flow of fluid from an D/ bag into patient in a manner controlled manually by a health care professional. The Klein Pump is not intended to be used as an IV infusion pump.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K031432 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031432: Klein Surgical Infiltration Pump, Model Kip-II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031432
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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