510(k) · Cleared
ClearedInsufflator (OPTO-IFL1000)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Optomedic Technologies, Inc. · HIF Insufflator, Laparoscopic
Cleared on Apr 16, 2026 as substantially equivalent to K222812 (Scivita Medical Technology Co., Ltd., 2023) after a 265-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Apr 16, 2026
- Review
- 265 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001533 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK001533 Surgiflator-40W.O.M. Gmhb · 2000
- 2 generations backK030837 40 L High Flow Insufflator F108W.O.M. World of Medicine AG · 2004
- 1 generation backK222812 InsufflatorScivita Medical Technology Co., Ltd. · 2023
- This deviceK252318 Insufflator (OPTO-IFL1000)Guangdong Optomedic Technologies, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001533 | Surgiflator-40 | W.O.M. Gmhb | 2000 | — |
| −2 | K030837 | 40 L High Flow Insufflator F108 | W.O.M. World of Medicine AG | 2004 | — |
| −1 | K222812 | Insufflator | Scivita Medical Technology Co., Ltd. | 2023 | — |
| 0 (this device) | K252318 | Insufflator (OPTO-IFL1000) | Guangdong Optomedic Technologies, Inc. | 2026 | — |
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.
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 26 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K222812.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 lnsufflator (OPTO-IFL 1000) is intended to generate and maintain pneumoperitoneum by filling the abdominal cavity with gas to distend it during diagnostic or therapeutic laparoscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252318 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252318: Insufflator (OPTO-IFL1000).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252318
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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