510(k) · Cleared
ClearedSurgiflator-20 Ecu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.O.M. World of Medicine GmbH · HIF Insufflator, Laparoscopic
Cleared on Jun 26, 1998 as substantially equivalent to K955791 (W.O.M. World of Medicine GmbH, 1996) after a 30-day review. Its family tree reaches back 2 generations to 1996. 31 later devices descend from it.
- Decided
- Jun 26, 1998
- Review
- 30 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950035 (1996). 31 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK950035 Surgiflator 20W.O.M. GmbH · 1996
- 1 generation backK955791 Surgiflator-20 PimW.O.M. World of Medicine GmbH · 1996
- This deviceK981859 Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998
- Descendant · cites it directly · 30 of its ownK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- Descendant · 2 generations on · 29 of its ownK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- Descendant · 3 generations on · 15 of its ownK062380 Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · Recalled
- Descendant · 4 generations on · 14 of its ownK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012
- Descendant · 5 generations on · 6 of its ownK123732 Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K990443Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999 · cites it directly30descendants
- K030402Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003 · 2 generations on29descendants
- K062380Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · 3 generations on15descendants
- K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012 · 4 generations on14descendants
- K123732Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950035 | Surgiflator 20 | W.O.M. GmbH | 1996 | — |
| −1 | K955791 | Surgiflator-20 Pim | W.O.M. World of Medicine GmbH | 1996 | — |
| 0 (this device) | K981859 | Surgiflator-20 Ecu | W.O.M. World of Medicine GmbH | 1998 | — |
| +1 | K990443 | Arthro-Surgimat-2000 Ecu | W.O.M. World of Medicine GmbH | 1999 | — |
| +2 | K030402 | Arthroscopy Pump, Model A107 | W.O.M. World of Medicine AG | 2003 | — |
| +3 | K062380 | Flosimple Arthroscopy Pump A120 | W.O.M. World of Medicine AG | 2006 | 1 |
| +4 | K112642 | Aquilex Fluid Control System H112 | W.O.M. World of Medicine AG | 2012 | — |
| +5 | K123732 | Hysteroscopy Pump HM6 | W.O.M. World of Medicine AG | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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 HIF? 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? (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 |
|---|---|---|---|
| * | K955791 | Surgiflator-20 PimSummary page 1…al cavity with gas to distend it. The Surgiflator-20 ECU described in this notification is a modified version of and substantially equivalent to the Surgiflator 20-PIM (K955791) which is manufactured by W.O.M. GmbH. The Surgiflator-20 ECU incorporates the same design features as the Surgiflator-20 PIM. T… | 1996 |
| † | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | 1998 |
What descends from it? (31)
See all 311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990443 | Arthro-Surgimat-2000 Ecu | 1999 | 30 |
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 2 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K990443 (W.O.M. World of Medicine GmbH, 1999) has gone furthest, with 30 descendants of its own.
- 1 other device also cites its predicate K955791.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
intraperitoneal high flow introduction of CO2 gas, under voice-activation control, for abdominal distention to facilitate laparoscopic visualization
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/K981859 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981859: Surgiflator-20 Ecu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981859
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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