510(k) · Cleared
ClearedLaparo CO2-Pneu (and with Video Monitoring)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · HIF Insufflator, Laparoscopic
Cleared on Sep 10, 1998 as substantially equivalent to K934884 (Richard Wolf Medical Instruments Corp., 1995) after a 150-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 10, 1998
- Review
- 150 days
- Class
- Class II
- Product code
- HIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934884 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK934884 Model 2231 CO2 InsufflatorRichard Wolf Medical Instruments Corp. · 1995
- This deviceK981334 Laparo CO2-Pneu (and with Video Monitoring)Richard Wolf Medical Instruments Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934884 | Model 2231 CO2 Insufflator | Richard Wolf Medical Instruments Corp. | 1995 | — |
| 0 (this device) | K981334 | Laparo CO2-Pneu (and with Video Monitoring) | Richard Wolf Medical Instruments Corp. | 1998 | — |
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? (4)
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 |
|---|---|---|---|
| * | K934884 | Model 2231 CO2 InsufflatorSummary page 1…11 Common name: Automatic Laparoscopic CO, Insufflator o lassification Name: Laparoscopic Insufflator 510(k) Number Trade or proprietary or model name Manufacturer 1 K934884 1 2231 Laparoscopic Insufflator 1 Richard Wolf 2 2 System 4000 2 CABOT 3 3 Medicam 900 3 MP Video 4 4 26012C 4 Karl Storz 1.0… | 1995 |
| * | — | System 4000 Named without a submission number | |
| * | — | Medicam 900 Named without a submission number | |
| * | — | 26012C Named without a submission number |
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?
- Its one ancestor has no recall.
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 Laparo CO2-Pneu generates and maintains pneumoperitoneum CO2 gas and can be used in diagnostic and 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/K981334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981334: Laparo CO2-Pneu (and with Video Monitoring).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981334
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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