510(k) · Cleared
ClearedEndomat Select (UP220)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz SE & CO. KG · HIG Insufflator, Hysteroscopic
Cleared on Jul 16, 2026 as substantially equivalent to K201355 (Karl Storz SE & CO. KG, 2020) after a 55-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Jul 16, 2026
- Review
- 55 days
- Class
- Class II
- Product code
- HIG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K950035 (1996). 43 ancestors in all, the oldest K903419 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK950035 Surgiflator 20W.O.M. GmbH · 1996
- 5 generations between
- 3 generations backK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012
- 2 generations backK180735 Endomat SelectKarl Storz SE & CO. KG · 2018
- 1 generation backK201355 Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG · 2020
- This deviceK261706 Endomat Select (UP220)Karl Storz SE & CO. KG · 2026
Show all 9 generations
- Root · 9 generations backK950035 Surgiflator 20W.O.M. GmbH · 1996
- 8 generations backK955791 Surgiflator-20 PimW.O.M. World of Medicine GmbH · 1996
- 7 generations backK981859 Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998
- 6 generations backK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- 5 generations backK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- 4 generations backK062380 Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · Recalled
- 3 generations backK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012
- 2 generations backK180735 Endomat SelectKarl Storz SE & CO. KG · 2018
- 1 generation backK201355 Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG · 2020
- This deviceK261706 Endomat Select (UP220)Karl Storz SE & CO. KG · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K950035 | Surgiflator 20 | W.O.M. GmbH | 1996 | — |
| −8 | K955791 | Surgiflator-20 Pim | W.O.M. World of Medicine GmbH | 1996 | — |
| −7 | K981859 | Surgiflator-20 Ecu | W.O.M. World of Medicine GmbH | 1998 | — |
| −6 | K990443 | Arthro-Surgimat-2000 Ecu | W.O.M. World of Medicine GmbH | 1999 | — |
| −5 | K030402 | Arthroscopy Pump, Model A107 | W.O.M. World of Medicine AG | 2003 | — |
| −4 | K062380 | Flosimple Arthroscopy Pump A120 | W.O.M. World of Medicine AG | 2006 | 1 |
| −3 | K112642 | Aquilex Fluid Control System H112 | W.O.M. World of Medicine AG | 2012 | — |
| −2 | K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018 | — |
| −1 | K201355 | Endomat Select, IBS Shaver Software, License | Karl Storz SE & CO. KG | 2020 | — |
| 0 (this device) | K261706 | Endomat Select (UP220) | Karl Storz SE & CO. KG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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 HIG? 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 HIG device
- #1 K251273 Asurys Fluid Management Systemscore 12.6 · 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? (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 |
|---|---|---|---|
| * | K201355 | Endomat Select, IBS Shaver Software, LicenseSummary page 5…Laparoscopic Insufflators: Submission Guidance for a 510(K) issued on August 1, Document: 1995 for Product Code HIG Predicate KARL STORZ Endomat Select (K201355) Devices: The predicate has not been subject to a design related recall. Device The Endomat Select i… | 2020 |
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?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 8 of the 43 ancestors have a recall of any class.
How does its category compare?
All HIG devicesHIG Insufflator, Hysteroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · HIG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HIG
175in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIG
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIG
45in 2025
MAUDE reports naming product code HIG, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 4 | 175 | 0 | 10 |
| 2019 | 0 | — | 0 | 66 |
| 2020 | 1 | — | 0 | 31 |
| 2021 | 1 | — | 0 | 130 |
| 2022 | 0 | — | 0 | 66 |
| 2023 | 0 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 45 |
| 2025 | 0 | — | 0 | 45 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Endomat Select is intended to: provide the infusion of the sterile irrigation solution into the ureter and upper urinary tract, as well as to suction irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures. provide the infusion of the sterile irrigation solution into the uterus, as well as to suction irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and…
Read the full statement (149 words)
Endomat Select is intended to:
provide the infusion of the sterile irrigation solution into the ureter and upper urinary tract, as well as to suction irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures.
provide the infusion of the sterile irrigation solution into the uterus, as well as to suction irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic hysteroscopic procedure.
provide the infusion of the sterile irrigation solution into organs and operating fields during diagnostic and operative endoscopic procedures in laparoscopic and open general surgery.
provide sustained liquid irrigation and distention of joint or intra-articular spaces as well as to suction irrigation fluids, bodily fluids, secretions, tissue and gas during all phases of arthroscopic surgery.
provide the infusion of the sterile irrigation solution in order to enable cleaning of the lens during endoscopically assisted Functional Endoscopic Sinus Surgery.
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/K261706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261706: Endomat Select (UP220).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261706
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026