510(k) · Cleared
Recalled · Class II · 2021Nebulae I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Northgate Technologies, Inc. · HIF Insufflator, Laparoscopic
Cleared on Aug 17, 2012 as substantially equivalent to K063367 (W.O.M. World of Medicine AG, 2007) and 1 other predicate after a 212-day review. Its family tree reaches back 5 generations to 1997. 22 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 17, 2012
- Review
- 212 days
- Class
- Class II
- Product code
- HIF
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 5 generations to K964171 (1997). 16 ancestors in all, the oldest K904993 (1991). 22 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK964171 Vasoview Balloon Dissection SystemOrigin Medsystems, Inc. · 1997
- 4 generations backK981700 Vasoview Dissection/Vessel Harvesting SystemOrigin Medsystems, Inc. · 1998
- 3 generations backK030512 Guidant Vasoview Endoscopic Vessel Harvesting SystemGuidant Corp. · 2003 · Recalled
- 2 generations backK060723 40 L High Flow Insufflator F113W.O.M. World of Medicine AG · 2006
- 1 generation backK063367 45L Core Insufflator, Model F114W.O.M. World of Medicine AG · 2007 · Recalled
- This deviceK120151 Nebulae INorthgate Technologies, Inc. · 2012
- Descendant · cites it directly · 21 of its ownK153513 Insufflator 50L FM134W.O.M. World of Medicine GmbH · 2016
- Descendant · 2 generations on · 17 of its ownK170784 PneumoclearW.O.M. World of Medicine GmbH · 2017 · Recalled
- Descendant · 3 generations on · 14 of its ownK201361 PneumoclearW.O.M. World of Medicine GmbH · 2020
- Descendant · 4 generations on · 11 of its ownK232610 da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube…Intuitive Surgical, Inc. · 2024 · Recalled
- Descendant · 5 generations on · 2 of its ownK251739 da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2026
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K153513Insufflator 50L FM134W.O.M. World of Medicine GmbH · 2016 · cites it directly21descendants
- K170784PneumoclearW.O.M. World of Medicine GmbH · 2017 · 2 generations on17descendants
- K201361PneumoclearW.O.M. World of Medicine GmbH · 2020 · 3 generations on14descendants
- K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc. · 2024 · 4 generations on11descendants
- K251739da Vinci Surgical System (IS5000)Intuitive Surgical, Inc. · 2026 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K964171 | Vasoview Balloon Dissection System | Origin Medsystems, Inc. | 1997 | — |
| −4 | K981700 | Vasoview Dissection/Vessel Harvesting System | Origin Medsystems, Inc. | 1998 | — |
| −3 | K030512 | Guidant Vasoview Endoscopic Vessel Harvesting System | Guidant Corp. | 2003 | 1 |
| −2 | K060723 | 40 L High Flow Insufflator F113 | W.O.M. World of Medicine AG | 2006 | — |
| −1 | K063367 | 45L Core Insufflator, Model F114 | W.O.M. World of Medicine AG | 2007 | 4 |
| 0 (this device) | K120151 | Nebulae I | Northgate Technologies, Inc. | 2012 | — |
| +1 | K153513 | Insufflator 50L FM134 | W.O.M. World of Medicine GmbH | 2016 | — |
| +2 | K170784 | Pneumoclear | W.O.M. World of Medicine GmbH | 2017 | 1 |
| +3 | K201361 | Pneumoclear | W.O.M. World of Medicine GmbH | 2020 | — |
| +4 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with… | Intuitive Surgical, Inc. | 2024 | 6 |
| +5 | K251739 | da Vinci Surgical System (IS5000) | Intuitive Surgical, Inc. | 2026 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 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 2…fflator for Laparoscopy and Endoscopic Vessel Harvesting Manufacturer: W.OM. World of Medicine 510(k) No. K063367 2. Device Name: 4OLPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0 Com… | 2007 |
| * | K022052 | 40LPM Abdominal Insufflator, Catalog # 72-00203-0Summary page 2…, CATALOG # 72-00203-0 Common Name: Insufflator Manufacturer: Northgate Technologies Inc. 510(k) No. K022052 4. Device Description The Nebulae TM 150 LPM Insufflator is microprocessor controlled. This CO2 (Carbon Dioxide) Hig… | 2003 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153513 | Insufflator 50L FM134 | 2016 | 21 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2021 | Class II | Z-1147-2021 | Nonconforming Material/Component | An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device. |
| Nov 21, 2016 | Class II | Z-0866-2017 | Software design | Device could cause a patient overpressure situation without any visual or auditory indication or warning |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 3 of the 16 ancestors have a recall of any class.
- Of its descendants, K153513 (W.O.M. World of Medicine GmbH, 2016) has gone furthest, with 21 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. 2012, 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 Nebulae TM 1 50 LPM Insufflator provides CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures:
General Laparoscopic
Pediatric Laparoscopic
Bariatric Laparoscopic
Minimally Invasive Vessel Harvesting
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120151: Nebulae I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120151
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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