510(k) · Cleared
ClearedAlpha Duo Lap Insufflator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hippokratec GmbH · HIF Insufflator, Laparoscopic
Cleared on Sep 25, 2009 as substantially equivalent to K011510 (Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh, 2002) and 2 other predicates after a 198-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Sep 25, 2009
- Review
- 198 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K001533 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
View 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) | K090652 | Alpha Duo Lap Insufflator | Hippokratec GmbH | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 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? (3)
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 |
|---|---|---|---|
| * | K011510 | Multi HI-Flo Pneu, Wisap #7080Summary page 2…s are produced by Company Property/ Device Name 510(k) No. WISAP Multi HI-FLO Pneu 7080 K011510 W.O.M. 40L High Flow Insufflator F108 K030837 SOPRO MODEL 640… | 2002 |
| * | K030837 | 40 L High Flow Insufflator F108Summary page 2…510(k) No. WISAP Multi HI-FLO Pneu 7080 K011510 W.O.M. 40L High Flow Insufflator F108 K030837 SOPRO MODEL 640 SOPRO LAPAROSCOPIC K070783… | 2004 |
| * | K070783 | Sopro Model 640 Laparoscopic InsufflatorSummary page 2…40L High Flow Insufflator F108 K030837 SOPRO MODEL 640 SOPRO LAPAROSCOPIC K070783 INSUFFLATOR Intended Use The intended use of the Laparoscopic Insufflator… | 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 9 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All HIF devicesHIF Insufflator, Laparoscopic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 intended use of the Laparoscopic Insufflator ALPHA DUO LAP is to establish and maintain a pneumoperitoneum with C02 gas for diagnostic or operative Laparoscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090652 · printed Nov 3, 2026
Cite this page
510(k) Report. “K090652: Alpha Duo Lap Insufflator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090652
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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