510(k) · Cleared
ClearedEndomat Select
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 Oct 31, 2018 as substantially equivalent to K112642 (W.O.M. World of Medicine AG, 2012) and 6 other predicates after a 223-day review. Its family tree reaches back 7 generations to 1996. 2 later devices descend from it.
- Decided
- Oct 31, 2018
- Review
- 223 days
- Class
- Class II
- Product code
- HIG
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 7 generations to K950035 (1996). 41 ancestors in all, the oldest K903419 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK950035 Surgiflator 20W.O.M. GmbH · 1996
- 6 generations backK955791 Surgiflator-20 PimW.O.M. World of Medicine GmbH · 1996
- 5 generations backK981859 Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998
- 4 generations backK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- 3 generations backK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- 2 generations backK062380 Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · Recalled
- 1 generation backK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012
- This deviceK180735 Endomat SelectKarl Storz SE & CO. KG · 2018
- Descendant · cites it directly · 1 of its ownK201355 Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KG · 2020
- Descendant · 2 generations on · 0 of its ownK261706 Endomat Select (UP220)Karl Storz SE & CO. KG · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K950035 | Surgiflator 20 | W.O.M. GmbH | 1996 | — |
| −6 | K955791 | Surgiflator-20 Pim | W.O.M. World of Medicine GmbH | 1996 | — |
| −5 | K981859 | Surgiflator-20 Ecu | W.O.M. World of Medicine GmbH | 1998 | — |
| −4 | K990443 | Arthro-Surgimat-2000 Ecu | W.O.M. World of Medicine GmbH | 1999 | — |
| −3 | K030402 | Arthroscopy Pump, Model A107 | W.O.M. World of Medicine AG | 2003 | — |
| −2 | K062380 | Flosimple Arthroscopy Pump A120 | W.O.M. World of Medicine AG | 2006 | 1 |
| −1 | K112642 | Aquilex Fluid Control System H112 | W.O.M. World of Medicine AG | 2012 | — |
| 0 (this device) | K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018 | — |
| +1 | K201355 | Endomat Select, IBS Shaver Software, License | Karl Storz SE & CO. KG | 2020 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2026 | 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 K261706 Endomat Select (UP220)score 14.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K112642 | Aquilex Fluid Control System H112 Our reading of the summary gave K112624, FDA’s number for Elecsys HE4, Elecsys HE4 Calset, Elecsys Precicontrol HE4… (Roche Diagnostics). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “World of Medicine AQUILEX FLUID CONTROL SYSTEM H112”. | 2012 |
| * | K122619 | Epix Irrigation Pump, Epix Suction Irrigation Tubing SetSummary page 5…ible or rigid) Predicate Device(s): World of Medicine AQUILEX FLUID CONTROL SYSTEM H112 (K112624), Applied Medical EPIX (K122619), World of Medicine Uro Pro (K042457), Karl Storz Endomat LC (K031457),… | 2012 |
| * | K042457 | Uro ProSummary page 5…ILEX FLUID CONTROL SYSTEM H112 (K112624), Applied Medical EPIX (K122619), World of Medicine Uro Pro (K042457), Karl Storz Endomat LC (K031457), Atherex Dual Wave Arthroscopy Pump (K083707),… | 2004 |
| * | K031457 | Endomat LC Pump, Model 20 3303 20Summary page 5…112624), Applied Medical EPIX (K122619), World of Medicine Uro Pro (K042457), Karl Storz Endomat LC (K031457), Atherex Dual Wave Arthroscopy Pump (K083707), Karl Storz ClearVision (K072410),… | 2004 |
| * | K083707 | Arthrex Dual Wave Arthroscopy Fluid Management DeviceSummary page 5…World of Medicine Uro Pro (K042457), Karl Storz Endomat LC (K031457), Atherex Dual Wave Arthroscopy Pump (K083707), Karl Storz ClearVision (K072410), Karl Storz Clear Vision (K013838)… | 2009 |
| * | K072410 | Ksea Clearvision II, Model 40334120Summary page 5…Karl Storz Endomat LC (K031457), Atherex Dual Wave Arthroscopy Pump (K083707), Karl Storz ClearVision (K072410), Karl Storz Clear Vision (K013838) **The above predicates have not been subject to… | 2008 |
| * | K013838 | Ksea Clearvision Lens Irrigation SystemSummary page 5…Atherex Dual Wave Arthroscopy Pump (K083707), Karl Storz ClearVision (K072410), Karl Storz Clear Vision (K013838) **The above predicates have not been subject to any recall** Device Description: The Endomat Select i… | 2002 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201355 | Endomat Select, IBS Shaver Software, License | 2020 | 1 |
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 22 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 8 of the 41 ancestors have a recall of any class.
- Of its descendants, K201355 (Karl Storz SE & CO. KG, 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K112642.
How does its category compare?
All HIG devicesHIG Insufflator, Hysteroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigations fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures provide liquid distention of the uterus for diagnostic and operative hysteroscopy provide the infusion of the sterile irrigant solutions into organs and operating fields…
Read the full statement (123 words)
Endomat Select is intended to:
provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigations fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures
provide liquid distention of the uterus for diagnostic and operative hysteroscopy
provide the infusion of the sterile irrigant solutions into organs and operating fields during diagnostic and operative procedures in laparoscopic and open general surgery
provide sustained liquid irrigation and distention of joint or intra-articular spaces during all phases of arthroscopic surgery
provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically assisted transnasal pituitary gland 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/K180735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K180735: Endomat Select.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K180735
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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