510(k) · Cleared
Recalled · Class I · 2026Uhi-3 High Flow Insufflation Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical Co., Ltd. · HIF Insufflator, Laparoscopic
Cleared on Jun 25, 2002 as substantially equivalent to K983326 (Northgate Technologies, Inc., 1999) after a 188-day review. Its family tree reaches back 1 generation to 1999. 3 of the 35 devices in its family, counting itself, have a Class I recall. 33 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Jun 25, 2002
- Review
- 188 days
- Class
- Class II
- Product code
- HIF
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K983326 (1999). 33 later devices descend from it, 1 citing it directly. 3 of the 35 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK983326 Omniflator 7640 Model 7-640-00Northgate Technologies, Inc. · 1999
- This deviceK014166 Uhi-3 High Flow Insufflation UnitOlympus Optical Co., Ltd. · 2002
- Descendant · cites it directly · 32 of its ownK110294 High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 31 of its ownK122180 High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · Recalled (Class I)
- Descendant · 3 generations on · 27 of its ownK143404 SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 17 of its ownK170784 PneumoclearW.O.M. World of Medicine GmbH · 2017 · Recalled
- Descendant · 5 generations on · 14 of its ownK201361 PneumoclearW.O.M. World of Medicine GmbH · 2020
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 33 · See all- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · cites it directly32descendants
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 2 generations on31descendants
- K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · 3 generations on27descendants
- K170784PneumoclearW.O.M. World of Medicine GmbH · 2017 · 4 generations on17descendants
- K201361PneumoclearW.O.M. World of Medicine GmbH · 2020 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983326 | Omniflator 7640 Model 7-640-00 | Northgate Technologies, Inc. | 1999 | — |
| 0 (this device) | K014166 | Uhi-3 High Flow Insufflation Unit | Olympus Optical Co., Ltd. | 2002 | — |
| +1 | K110294 | High Flow Insufflation Unit Uhi-4 | Olympus Medical Systems Corporation | 2011 | Class I |
| +2 | K122180 | High Flow Insufflantion Unit | Olympus Medical Systems Corporation | 2012 | Class I |
| +3 | K143404 | SurgiQuest AirSeal iFS System | Surgiquest, Inc. | 2015 | 11 |
| +4 | K170784 | Pneumoclear | W.O.M. World of Medicine GmbH | 2017 | 1 |
| +5 | K201361 | Pneumoclear | W.O.M. World of Medicine GmbH | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
| 2012 | 1 | 1 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 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.
3 devices in this family have a Class I recall. 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K095316 | OLYMPUS High Flow Insufflation Unit (UHI) Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | K983326 | Omniflator 7640 Model 7-640-00Summary page 2…of this subject device is 35 llmin over the current FDA's cleared level. However the maximum flow rate of OMNIFLATOR 7640 MODEL 7-640-00 cleared in the previous 51O(k) (#983326)is 40 bin. And when compared to the predicated devices listed above, the Olympus High Flow lnsufflatian Unit UHI-… | 1999 |
What descends from it? (33)
See all 331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110294 | High Flow Insufflation Unit Uhi-4 Class I | 2011 | 32 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 16, 2026 | Class I | Z-1354-2026 | Software design | Issue with software algorithm which may lead to overpressure events. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K110294 (Olympus Medical Systems Corporation, 2011) has gone furthest, with 32 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?
This instrument has been designed for insufflation of the abdominal cavity, and
automatic suction and smoke evacuation. This instrument uses C 0 2gas for
distension, and it may be used for diagnostic andlor operative laparoscopy,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K014166 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014166: Uhi-3 High Flow Insufflation Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014166
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026