510(k) · Cleared
ClearedHydrofloex HD Hysteroscopic Distention System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Davol Inc., Sub. C. R. Bard, Inc. · HIG Insufflator, Hysteroscopic
Cleared on Dec 11, 1997 as substantially equivalent to K933873 (Linvatec Corp., 1994) after a 336-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Dec 11, 1997
- Review
- 336 days
- Class
- Class II
- Product code
- HIG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K933873 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK933873 Concept Universal Pump SystemLinvatec Corp. · 1994
- This deviceK970078 Hydrofloex HD Hysteroscopic Distention SystemDavol Inc., Sub. C. R. Bard, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK982867 Hydroflex HD Hysteroscopic Distention System,Model #'S 0025360…Davol Inc., Sub. C. R. Bard, Inc. · 1999
Most influential descendants
Showing 1 of 1 · See all- K982867Hydroflex HD Hysteroscopic Distention System,Model #'S 0025360, 0025370, 0025000Davol Inc., Sub. C. R. Bard, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933873 | Concept Universal Pump System | Linvatec Corp. | 1994 | — |
| 0 (this device) | K970078 | Hydrofloex HD Hysteroscopic Distention System | Davol Inc., Sub. C. R. Bard, Inc. | 1997 | — |
| +1 | K982867 | Hydroflex HD Hysteroscopic Distention System,Model #'S 0025360, 0025370, 0025000 | Davol Inc., Sub. C. R. Bard, Inc. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K901068 | Zimmer CDIS Controlled Distention Irrigation System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…m Common/Usual Name: Hysteroscopic Distention System Classification Name: Hysteroscopic Insufflator, Obstetrics & Gynecology Predicate Device: - Zimmer CDIS System (K901068) - Linvatec Apex™ Universal Irrigation System (K933873) The HydroFlex HD system proposed in this submission is substantially equ… | |
| * | K933873 | Concept Universal Pump SystemSummary page 1…Classification Name: Hysteroscopic Insufflator, Obstetrics & Gynecology Predicate Device: - Zimmer CDIS System (K901068) - Linvatec Apex™ Universal Irrigation System (K933873) The HydroFlex HD system proposed in this submission is substantially equivalent to the Zimmer CDIS™ Controlled Distention Irrig… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982867 | Hydroflex HD Hysteroscopic Distention System,Model #'S 0025360, 0025370, 0025000 | 1999 | 0 |
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?
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 HydroFlex HD Hysteroscopic Distention System is intended to provide distention and irrigation of the uterus with low viscosity fluids during diagnostic or 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/K970078 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970078: Hydrofloex HD Hysteroscopic Distention System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970078
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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