510(k) · Cleared
Cleared40LPM Abdominal Insufflator, Catalog # 72-00203-0
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 Jan 24, 2003 after a 214-day review. The FDA summary names no predicate by number. 23 later devices descend from it.
- Decided
- Jan 24, 2003
- Review
- 214 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 1 citing it directly.
- This deviceK022052 40LPM Abdominal Insufflator, Catalog # 72-00203-0Northgate Technologies, Inc. · 2003
- Descendant · cites it directly · 22 of its ownK120151 Nebulae INorthgate Technologies, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 21 of its ownK153513 Insufflator 50L FM134W.O.M. World of Medicine GmbH · 2016
- Descendant · 3 generations on · 17 of its ownK170784 PneumoclearW.O.M. World of Medicine GmbH · 2017 · Recalled
- Descendant · 4 generations on · 14 of its ownK201361 PneumoclearW.O.M. World of Medicine GmbH · 2020
- Descendant · 5 generations on · 11 of its ownK232610 da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube…Intuitive Surgical, Inc. · 2024 · Recalled
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K120151Nebulae INorthgate Technologies, Inc. · 2012 · cites it directly22descendants
- K153513Insufflator 50L FM134W.O.M. World of Medicine GmbH · 2016 · 2 generations on21descendants
- K170784PneumoclearW.O.M. World of Medicine GmbH · 2017 · 3 generations on17descendants
- K201361PneumoclearW.O.M. World of Medicine GmbH · 2020 · 4 generations on14descendants
- K232610da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…Intuitive Surgical, Inc. · 2024 · 5 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022052 | 40LPM Abdominal Insufflator, Catalog # 72-00203-0 | Northgate Technologies, Inc. | 2003 | — |
| +1 | K120151 | Nebulae I | Northgate Technologies, Inc. | 2012 | 2 |
| +2 | K153513 | Insufflator 50L FM134 | W.O.M. World of Medicine GmbH | 2016 | — |
| +3 | K170784 | Pneumoclear | W.O.M. World of Medicine GmbH | 2017 | 1 |
| +4 | K201361 | Pneumoclear | W.O.M. World of Medicine GmbH | 2020 | — |
| +5 | K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with… | Intuitive Surgical, Inc. | 2024 | 6 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (23)
See all 231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120151 | Nebulae I | 2012 | 22 |
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?
- Of its descendants, K120151 (Northgate Technologies, Inc., 2012) has gone furthest, with 22 descendants of its own.
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 NORTECH 40LPM ABDOMINAL INSUFFLATOR, 72-00203-0 SHALL BE USED FOR GAS DISTENTION OF THE ABDOMEN FOR OPERATIVE LAPAROSCOPY.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022052: 40LPM Abdominal Insufflator, Catalog # 72-00203-0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022052
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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