510(k) · Cleared
ClearedENDOFLATOR+; Smart Smoke Evacuation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Karl Storz SE & CO. KG · HIF Insufflator, Laparoscopic
Cleared on Aug 19, 2026 as substantially equivalent to K250388 (Karl Storz SE & CO. KG, 2025) and 2 other predicates after a 208-day review. Its family tree reaches back 12 generations to 1993. 3 of the 55 devices in its family, counting itself, have a Class I recall.
- Decided
- Aug 19, 2026
- Review
- 208 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K931783 (1993). 54 ancestors in all, the oldest K864584 (1986). No later device cites it as a predicate yet. 3 of the 55 devices in this family, counting this one, have a Class I recall.
- Root · 12 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 8 generations between
- 3 generations backK181258 ConnectedOR Hub with Device and Voice ControlStryker · 2018
- 2 generations backK192172 Connected OR Hub with Device and Voice ControlStryker · 2019
- 1 generation backK201434 Connected OR Hub with Voice Control, Connected OR Hub with Device…Stryker · 2020
- This deviceK260209 ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG · 2026
Show all 12 generations
- Root · 12 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 11 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 10 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 9 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 8 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
- 7 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
- 6 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
- 5 generations backK121893 Stryker SDC3 HD Information Management SystemStryker Endoscopy · 2012
- 4 generations backK160332 Stryker SDC3 HD Information Management System with Wireless Device…Stryker Endoscopy · 2016
- 3 generations backK181258 ConnectedOR Hub with Device and Voice ControlStryker · 2018
- 2 generations backK192172 Connected OR Hub with Device and Voice ControlStryker · 2019
- 1 generation backK201434 Connected OR Hub with Voice Control, Connected OR Hub with Device…Stryker · 2020
- This deviceK260209 ENDOFLATOR+; Smart Smoke EvacuationKarl Storz SE & CO. KG · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −11 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −10 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −9 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −8 | K990691 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1999 | — |
| −7 | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). | Computer Motion, Inc. | 1999 | — |
| −6 | K022393 | Merdoc System | Stryker Endoscopy | 2003 | — |
| −5 | K121893 | Stryker SDC3 HD Information Management System | Stryker Endoscopy | 2012 | — |
| −4 | K160332 | Stryker SDC3 HD Information Management System with Wireless Device Control… | Stryker Endoscopy | 2016 | — |
| −3 | K181258 | ConnectedOR Hub with Device and Voice Control | Stryker | 2018 | — |
| −2 | K192172 | Connected OR Hub with Device and Voice Control | Stryker | 2019 | — |
| −1 | K201434 | Connected OR Hub with Voice Control, Connected OR Hub with Device Control | Stryker | 2020 | — |
| 0 (this device) | K260209 | ENDOFLATOR+; Smart Smoke Evacuation | Karl Storz SE & CO. KG | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 1 |
| 2003 | 5 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 1 |
| 2012 | 2 | 1 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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.
3 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 HIF device
- #1 K250388 Endoflator +score 15.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K250388 | Endoflator +Summary page 5…de: HIF (primary), OSV (secondary) Regulatory Class: Class II Predicate Device(s): Insufflator predicates: K250388 KARL STORZ ENDOFLATOR + K201361 W.O.M. World of Medicine GmbH PNEUMOCLEAR… | 2025 |
| * | K201361 | PneumoclearSummary page 5…Regulatory Class: Class II Predicate Device(s): Insufflator predicates: K250388 KARL STORZ ENDOFLATOR + K201361 W.O.M. World of Medicine GmbH PNEUMOCLEAR Smart Smoke predicate: K201434… | 2020 |
| * | K201434 | Connected OR Hub with Voice Control, Connected OR Hub with Device ControlSummary page 5…ENDOFLATOR + K201361 W.O.M. World of Medicine GmbH PNEUMOCLEAR Smart Smoke predicate: K201434 Stryker Connected OR Hub with Voice and Device Control The predicate devices have not been subject… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 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.
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 4 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 5 generations back · ◆ in the 2011 ancestors bar of FIG. 11 Class I recall
- K014166Uhi-3 High Flow Insufflation UnitOlympus Optical Co., Ltd. · 2002 · 6 generations back · ◆ in the 2002 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 11 of the 54 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · HIF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIF
210in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIF
12so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HIF
1,507in 2025
MAUDE reports naming product code HIF, 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 | 4 | 140 | 0 | 8 |
| 2008 | 2 | — | 1 | 14 |
| 2009 | 4 | 191 | 0 | 21 |
| 2010 | 2 | — | 0 | 41 |
| 2011 | 5 | 128 | 0 | 44 |
| 2012 | 5 | 138 | 0 | 38 |
| 2013 | 2 | — | 0 | 40 |
| 2014 | 2 | — | 0 | 43 |
| 2015 | 2 | — | 0 | 30 |
| 2016 | 3 | 88 | 1 | 72 |
| 2017 | 5 | 242 | 0 | 68 |
| 2018 | 3 | 207 | 1 | 97 |
| 2019 | 2 | — | 0 | 128 |
| 2020 | 4 | 64 | 0 | 360 |
| 2021 | 1 | — | 0 | 654 |
| 2022 | 1 | — | 0 | 667 |
| 2023 | 7 | 134 | 1 (1) | 890 |
| 2024 | 4 | 170 | 0 | 1,483 |
| 2025 | 3 | 210 | 0 | 1,507 |
| 2026 | 3 | 265 | 12 | — |
What is it indicated for?
The ENDOFLATOR + is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with CO2 gas with the following operating modes: High Flow mode is indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. Pediatric mode is indicated to fill and distend a peritoneal cavity with gas during a pediatric laparoscopic procedure. EVH mode is indicated for use…
Read the full statement (136 words)
The ENDOFLATOR + is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with CO2 gas with the following operating modes:
High Flow mode is indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure.
Pediatric mode is indicated to fill and distend a peritoneal cavity with gas during a pediatric laparoscopic procedure.
EVH mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.
taTME mode is indicated to fill and distend the rectum and colon using CO2 gas during transanal minimally invasive surgery.
The smart smoke evacuation software is an optional feature that triggers smoke evacuation of the compatible insufflator through analysis of the smoke volume in the endoscopic image.
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/K260209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260209: ENDOFLATOR+; Smart Smoke Evacuation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260209
Report an extraction error
Are you the manufacturer?
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