510(k) · Cleared
ClearedSurgiflator-20 Pim
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 Dec 17, 1996 as substantially equivalent to K950035 (W.O.M. GmbH, 1996) after a 361-day review. Its family tree reaches back 1 generation to 1996. 33 later devices descend from it.
- Decided
- Dec 17, 1996
- Review
- 361 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950035 (1996). 33 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK950035 Surgiflator 20W.O.M. GmbH · 1996
- This deviceK955791 Surgiflator-20 PimW.O.M. World of Medicine GmbH · 1996
- Descendant · cites it directly · 31 of its ownK981859 Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998
- Descendant · 2 generations on · 30 of its ownK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- Descendant · 3 generations on · 29 of its ownK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- Descendant · 4 generations on · 15 of its ownK062380 Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · Recalled
- Descendant · 5 generations on · 14 of its ownK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K981859Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998 · cites it directly31descendants
- K990443Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999 · 2 generations on30descendants
- K030402Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003 · 3 generations on29descendants
- K062380Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · 4 generations on15descendants
- K112642Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950035 | Surgiflator 20 | W.O.M. GmbH | 1996 | — |
| 0 (this device) | K955791 | Surgiflator-20 Pim | W.O.M. World of Medicine GmbH | 1996 | — |
| +1 | K981859 | Surgiflator-20 Ecu | W.O.M. World of Medicine GmbH | 1998 | — |
| +2 | 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 | — |
| +4 | K062380 | Flosimple Arthroscopy Pump A120 | W.O.M. World of Medicine AG | 2006 | 1 |
| +5 | K112642 | Aquilex Fluid Control System H112 | W.O.M. World of Medicine AG | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K950035 | Surgiflator 20 Cleared while this submission was under review Summary page 1…ty with CO, to enable laparoscopic procedures. The Surgiflator-20 PIM described in this notification is similar in design and construction to the W.0.M. Surgiflator 20, K950035 and the Snowden-Pencer High Flow Insufflator, Model 89-8600 and Model SP 88-9700, distributed in the United States by Snowden-Pen… | 1996 |
| * | — | Snowden-Pencer High Flow Insufflator, Model 89-8600 Named without a submission number | |
| * | — | Snowden-Pencer High Flow Insufflator, Model SP 88-9700 Named without a submission number |
What descends from it? (33)
See all 332 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?
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?
The Surgiflator-20 PIM is a laparoscopic high flow insufflator intended to fill the abdominal cavity with CO, to enable laparoscopic procedures.
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/K955791 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955791: Surgiflator-20 Pim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955791
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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