510(k) · Cleared
ClearedHys-Surgiflator 150P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W.O.M. World of Medicine GmbH · HIG Insufflator, Hysteroscopic
Cleared on Jan 14, 1999 as substantially equivalent to K922632 (W.O.M. GmbH, 1994) after a 73-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jan 14, 1999
- Review
- 73 days
- Class
- Class II
- Product code
- HIG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922632 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK922632 Wom Hysteroflator OPW.O.M. GmbH · 1994
- This deviceK983889 Hys-Surgiflator 150PW.O.M. World of Medicine GmbH · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922632 | Wom Hysteroflator OP | W.O.M. GmbH | 1994 | — |
| 0 (this device) | K983889 | Hys-Surgiflator 150P | W.O.M. World of Medicine GmbH | 1999 | — |
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? (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 |
|---|---|---|---|
| * | K922632 | Wom Hysteroflator OPSummary page 1…ilitate viewing with a hysteroscope (21 C.F.R. § 884.1700). The HYS-Surgiflator /S0P described in this nofification is substantially equivelant to the Hysteroflator OP, K922632/B, manufactured by W.O.M. GmbH. The HYS-Surgiflator ~ OP incorporates the same design features as the Hysteroflator OP K922632/B.… | 1994 |
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 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 HYS-Surgiflator 150P is a hysteroscopic insufflator intended to distend the uterus by fillng the uterine cavity with a gas to facilitate viewing with a hysteroscope (21 C.F.R. § 884.1700).
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/K983889 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983889: Hys-Surgiflator 150P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983889
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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