510(k) · Cleared
ClearedInsufflator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scivita Medical Technology Co., Ltd. · HIF Insufflator, Laparoscopic
Cleared on May 16, 2023 as substantially equivalent to K030837 (W.O.M. World of Medicine AG, 2004) after a 239-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- May 16, 2023
- Review
- 239 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001533 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001533 Surgiflator-40W.O.M. Gmhb · 2000
- 1 generation backK030837 40 L High Flow Insufflator F108W.O.M. World of Medicine AG · 2004
- This deviceK222812 InsufflatorScivita Medical Technology Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK252584 Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A…Weyo Surgical Technology, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252318 Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001533 | Surgiflator-40 | W.O.M. Gmhb | 2000 | — |
| −1 | K030837 | 40 L High Flow Insufflator F108 | W.O.M. World of Medicine AG | 2004 | — |
| 0 (this device) | K222812 | Insufflator | Scivita Medical Technology Co., Ltd. | 2023 | — |
| +1 | K252584 | Insufflator (wAlcor C50A, wAlcor C50B, wAlcor C50C, wAlcor C35A, wAlcor C35B… | Weyo Surgical Technology, Ltd. | 2026 | — |
| +1 | K252318 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K030837 | 40 L High Flow Insufflator F108Summary page 6…Page 3 of 7 5. Identification of Predicate Devices Predicate Device 510(k) Number: K030837 Trade/Device Name: 40 L HIGH FLOW INSUFFLATOR F108 The predicate device has not been subject to a design-related… | 2004 |
| † | K153513 | Insufflator 50L FM134 | 2016 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 3 companies; a new generation was cleared every 19.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K252584 (Weyo Surgical Technology, Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K030837.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Insufflator is a device intended to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222812 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222812: Insufflator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222812
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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