510(k) · Cleared
ClearedHystero CO2-Pneu 2221
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · HIG Insufflator, Hysteroscopic
Cleared on Jan 10, 1997 as substantially equivalent to K880314 (Richard Wolf Medical Instruments Corp., 1988) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Jan 10, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- HIG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K880314 (1988). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK880314 Hysteroscope Autonom 4992Richard Wolf Medical Instruments Corp. · 1988
- This deviceK964136 Hystero CO2-Pneu 2221Richard Wolf Medical Instruments Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K880314 | Hysteroscope Autonom 4992 | Richard Wolf Medical Instruments Corp. | 1988 | — |
| 0 (this device) | K964136 | Hystero CO2-Pneu 2221 | Richard Wolf Medical Instruments Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 HIG? 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 HIG device
- #1 K261706 Endomat Select (UP220)score 14.1 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K880314 | Hysteroscope Autonom 4992Summary page 1…fflator, Hysteroscopic Inft al d: I 510(k) Number Trade or proprietary or model name Manufacturer 1 pre enact. 1 Hysteroscopy-Insufflator 2020 1 Richard Wolf M.I.C. 2 K880314 2 Hysteroscope Autonom 4992 2 Richard Wolf M.1.C. 3 K924523 3 __HYS - Surgiflator 3 WOM GmbH, Germany 4 4 Hamou-Micro-Hysterofla… | 1988 |
| * | K924523 | Hys-SurgiflatorSummary page 1…roprietary or model name Manufacturer 1 pre enact. 1 Hysteroscopy-Insufflator 2020 1 Richard Wolf M.I.C. 2 K880314 2 Hysteroscope Autonom 4992 2 Richard Wolf M.1.C. 3 K924523 3 __HYS - Surgiflator 3 WOM GmbH, Germany 4 4 Hamou-Micro-Hysteroflator 4 Karl Storz 5 5 Hystero-Insufflator Electronic 5 WISAP… | 1995 |
| * | — | Hysteroscopy-Insufflator 2020 Named without a submission number | |
| * | — | Hamou-Micro-Hysteroflator Named without a submission number | |
| * | — | Hystero-Insufflator Electronic 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?
- None of the 2 ancestors has a recall.
- 4 other devices also cite its predicate K880314.
How does its category compare?
All HIG devicesHIG Insufflator, Hysteroscopic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HIG
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HIG
175in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIG
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIG
45in 2025
MAUDE reports naming product code HIG, 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 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 1 | — | 0 | 5 |
| 2014 | 1 | — | 0 | 9 |
| 2015 | 0 | — | 0 | 10 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 11 |
| 2018 | 4 | 175 | 0 | 10 |
| 2019 | 0 | — | 0 | 66 |
| 2020 | 1 | — | 0 | 31 |
| 2021 | 1 | — | 0 | 130 |
| 2022 | 0 | — | 0 | 66 |
| 2023 | 0 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 45 |
| 2025 | 0 | — | 0 | 45 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Hystero CO₂-Pneu is designed for dilating the cavum uteri with CO₂ gas during diagnostic and operative hysteroscopy.
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/K964136 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964136: Hystero CO2-Pneu 2221.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964136
Report an extraction error
Are you the manufacturer?
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