510(k) · Cleared
ClearedInsufflator 50L FM134
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 Mar 4, 2016 as substantially equivalent to K063367 (W.O.M. World of Medicine AG, 2007) and 1 other predicate after an 88-day review. Its family tree reaches back 6 generations to 1997. 21 later devices descend from it.
- Decided
- Mar 4, 2016
- Review
- 88 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K964171 (1997). 17 ancestors in all, the oldest K904993 (1991). 21 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK964171 Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
- 5 generations backK981700 Vasoview Dissection/Vessel Harvesting SystemOrigin Medsystems, Inc. · 1998
- 4 generations backK030512 Guidant Vasoview Endoscopic Vessel Harvesting SystemGuidant Corp. · 2003 · Recalled
- 3 generations backK060723 40 L High Flow Insufflator F113W.O.M. World of Medicine AG · 2006
- 2 generations backK063367 45L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · Recalled
- 1 generation backK120151 Nebulae INorthgate Technologies, Inc. · 2012 · Recalled
- This deviceK153513 Insufflator 50L FM134W.O.M. World of Medicine GmbH · 2016
- Descendant · cites it directly · 17 of its ownK170784 PneumoclearW.O.M. World of Medicine GmbH · 2017 · Recalled
- Descendant · 2 generations on · 14 of its ownK201361 PneumoclearW.O.M. World of Medicine GmbH · 2020
- Descendant · 3 generations on · 11 of its ownK232610 da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube…Intuitive Surgical, Inc. · 2024 · Recalled
- Descendant · 4 generations on · 2 of its ownK251739 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2026
- Descendant · 4 generations on · 2 of its ownK241284 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2024
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K170784PneumoclearW.O.M. World of Medicine GmbH · 2017 · cites it directly17descendants
- K201361PneumoclearW.O.M. World of Medicine GmbH · 2020 · 2 generations on14descendants
- K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc. · 2024 · 3 generations on11descendants
- K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2026 · 4 generations on2descendants
- K241284da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K964171 | Vasoview Balloon Dissection System | Origin Medsystems, Inc. | 1997 | — |
| −5 | K981700 | Vasoview Dissection/Vessel Harvesting System | Origin Medsystems, Inc. | 1998 | — |
| −4 | K030512 | Guidant Vasoview Endoscopic Vessel Harvesting System | Guidant Corp. | 2003 | 1 |
| −3 | K060723 | 40 L High Flow Insufflator F113 | W.O.M. World of Medicine AG | 2006 | — |
| −2 | K063367 | 45L Core Insufflator, Model F114 | W.O.M. World of Medicine AG | 2007 | 4 |
| −1 | K120151 | Nebulae I | Northgate Technologies, Inc. | 2012 | 2 |
| 0 (this device) | K153513 | Insufflator 50L FM134 | W.O.M. World of Medicine GmbH | 2016 | — |
| +1 | K170784 | Pneumoclear | W.O.M. World of Medicine GmbH | 2017 | 1 |
| +2 | K201361 | Pneumoclear | W.O.M. World of Medicine GmbH | 2020 | — |
| +3 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with… | Intuitive Surgical, Inc. | 2024 | 6 |
| +4 | K251739 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2026 | — |
| +4 | K241284 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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? (2)
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 |
|---|---|---|---|
| * | K063367 | 45L Core Insufflator, Model F114Summary page 4…HIF, OSV 3) Predicate Devices: Primary Predicate Device: Trade Name: 45L Core Insufflator F114 510(k) Number: K063367 Classification Name: Insufflator, Laparoscopic Regulation Number and Name: 21 CFR 884.1730, Laparoscopic Ins… | 2007 |
| * | K120151 | Nebulae ISummary page 5…(k) Premarket Notification Secondary Predicate Device: Trade Name: Nebulae™ I 50 LPM Insufflator 510(k) Number: K120151 Classification Name: Insufflator, Laparoscopic Regulation Number and Name: 21 CFR 884.1730, La… | 2012 |
What descends from it? (21)
See all 213 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?
- The line of descent spans 19 years and passes through 5 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 17 ancestors have a recall of any class.
- Of its descendants, K170784 (W.O.M. World of Medicine GmbH, 2017) has gone furthest, with 17 descendants of its own.
- 6 other devices also cite its predicate K063367.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 device Insufflator 50L FM134 is a CO2 insufflator intended for use during diagnostic and/or therapeutic endoscopic procedures to distend a cavity by filling it with gas. The Standard, Pediatric and Bariatric operating modes of the device are indicated to fill and distend a peritoneal cavity with gas during a laparoscopic procedure. The Pediatric operating mode is specifically indicated for pediatric laparoscopic procedures. The Vessel Harvesting operating mode is indicated for use during endoscopic vessel harvesting procedures to create a cavity along the saphenous vein or radial artery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153513: Insufflator 50L FM134.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153513
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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