510(k) · Cleared
ClearedOmniflator 7640 Model 7-640-00
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 Feb 5, 1999 after a 136-day review. The FDA summary names no predicate by number. 3 of the 35 devices in its family, counting itself, have a Class I recall. 34 later devices descend from it.
- Decided
- Feb 5, 1999
- Review
- 136 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 0
34 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.
- This deviceK983326 Omniflator 7640 Model 7-640-00Northgate Technologies, Inc. · 1999
- Descendant · cites it directly · 33 of its ownK014166 Uhi-3 High Flow Insufflation UnitOlympus Optical Co., Ltd. · 2002 · Recalled (Class I)
- Descendant · 2 generations on · 32 of its ownK110294 High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · Recalled (Class I)
- Descendant · 3 generations on · 31 of its ownK122180 High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · Recalled (Class I)
- Descendant · 4 generations on · 27 of its ownK143404 SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · Recalled
- Descendant · 5 generations on · 17 of its ownK170784 PneumoclearW.O.M. World of Medicine GmbH · 2017 · Recalled
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 34 · See all- K014166Uhi-3 High Flow Insufflation UnitOlympus Optical Co., Ltd. · 2002 · cites it directly33descendants
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 2 generations on32descendants
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 3 generations on31descendants
- K143404SurgiQuest AirSeal iFS SystemSurgiquest, Inc. · 2015 · 4 generations on27descendants
- K170784PneumoclearW.O.M. World of Medicine GmbH · 2017 · 5 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983326 | Omniflator 7640 Model 7-640-00 | Northgate Technologies, Inc. | 1999 | — |
| +1 | K014166 | Uhi-3 High Flow Insufflation Unit | Olympus Optical Co., Ltd. | 2002 | Class I |
| +2 | K110294 | High Flow Insufflation Unit Uhi-4 | Olympus Medical Systems Corporation | 2011 | Class I |
| +3 | K122180 | High Flow Insufflantion Unit | Olympus Medical Systems Corporation | 2012 | Class I |
| +4 | K143404 | SurgiQuest AirSeal iFS System | Surgiquest, Inc. | 2015 | 11 |
| +5 | K170784 | Pneumoclear | W.O.M. World of Medicine GmbH | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 1 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K014166 | Uhi-3 High Flow Insufflation Unit Class I | 2002 | 33 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
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.
- K014166Uhi-3 High Flow Insufflation UnitOlympus Optical Co., Ltd. · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
- K110294High Flow Insufflation Unit Uhi-4Olympus Medical Systems Corporation · 2011 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
- K122180High Flow Insufflantion UnitOlympus Medical Systems Corporation · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K014166 (Olympus Optical Co., Ltd., 2002) has gone furthest, with 33 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 OMNIFLATOR® 7640 SHALL BE USED FOR GAS
DISTENTION OF THE ABDOMEN FOR DIAGNOSTIC AND / OR OPERATIVE
LAPAROSCOPY.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983326: Omniflator 7640 Model 7-640-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983326
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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