510(k) · Cleared
ClearedHumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Healthcare · HIF Insufflator, Laparoscopic
Cleared on Jun 23, 2017 as substantially equivalent to K063546 (Lexion Medical, LLC, 2007) after a 281-day review. Its family tree reaches back 3 generations to 1992.
- Decided
- Jun 23, 2017
- Review
- 281 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K920986 (1992). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK920986 Snowden-Pencer High Flow Insufflator, SP/88-9700Snowden-Pencer · 1992
- 2 generations backK970866 Filter Heater/Hydrator Insufflation Gas ConditionerGeorgia Biomedical, Inc. · 1998
- 1 generation backK063546 Insuflow Device, Model 6198Lexion Medical, LLC · 2007
- This deviceK162582 HumiGard Surgical Humidification System, HumiGard Humdified…Fisher & Paykel Healthcare · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920986 | Snowden-Pencer High Flow Insufflator, SP/88-9700 | Snowden-Pencer | 1992 | — |
| −2 | K970866 | Filter Heater/Hydrator Insufflation Gas Conditioner | Georgia Biomedical, Inc. | 1998 | — |
| −1 | K063546 | Insuflow Device, Model 6198 | Lexion Medical, LLC | 2007 | — |
| 0 (this device) | K162582 | HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit | Fisher & Paykel Healthcare | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 2 | 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 |
|---|---|---|---|
| * | K063546 | Insuflow Device, Model 6198Summary page 4…Product Code HIF Class II Predicate device Lexion Medical Insuflow Device, Model 6198 (K063546) The predicate device has not been subject to a design related… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 4 companies; a new generation was cleared every 9.0 years on median.
- None of the 6 ancestors has a recall.
- 4 other devices also cite its predicate K063546.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 HumiGard Surgical Humidification System is intended to warm and humidify carbon dioxide gas from an insufflator prior to entry into the surgical cavity during laparoscopic surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162582: HumiGard Surgical Humidification System, HumiGard Humdified Insufflation Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162582
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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