510(k) · Cleared
ClearedAveta System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meditrina, Inc. · HIH Hysteroscope (And Accessories)
Cleared on May 16, 2019 as substantially equivalent to K152143 (Smith & Nephew, Inc., 2015) and 2 other predicates after a 90-day review. Its family tree reaches back 8 generations to 1996. 4 later devices descend from it.
- Decided
- May 16, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K950035 (1996). 41 ancestors in all, the oldest K903419 (1990). 4 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK950035 Surgiflator 20W.O.M. GmbH · 1996
- 7 generations backK955791 Surgiflator-20 PimW.O.M. World of Medicine GmbH · 1996
- 6 generations backK981859 Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998
- 5 generations backK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- 4 generations backK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- 3 generations backK062380 Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · Recalled
- 2 generations backK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012
- 1 generation backK123732 Hysteroscopy Pump HM6W.O.M. World of Medicine AG · 2013
- This deviceK190372 Aveta SystemMeditrina, Inc. · 2019
- Descendant · cites it directly · 1 of its ownK213171 Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral)…Meditrina, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK223813 Aveta System 2.0Meditrina, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK192100 Aveta Disposable HysteroscopeMeditrina, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK191958 Aveta SystemMeditrina, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K213171Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable…Meditrina, Inc. · 2022 · cites it directly1descendant
- K223813Aveta System 2.0Meditrina, Inc. · 2023 · 2 generations on0descendants
- K192100Aveta Disposable HysteroscopeMeditrina, Inc. · 2019 · cites it directly0descendants
- K191958Aveta SystemMeditrina, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K950035 | Surgiflator 20 | W.O.M. GmbH | 1996 | — |
| −7 | K955791 | Surgiflator-20 Pim | W.O.M. World of Medicine GmbH | 1996 | — |
| −6 | K981859 | Surgiflator-20 Ecu | W.O.M. World of Medicine GmbH | 1998 | — |
| −5 | K990443 | Arthro-Surgimat-2000 Ecu | W.O.M. World of Medicine GmbH | 1999 | — |
| −4 | K030402 | Arthroscopy Pump, Model A107 | W.O.M. World of Medicine AG | 2003 | — |
| −3 | K062380 | Flosimple Arthroscopy Pump A120 | W.O.M. World of Medicine AG | 2006 | 1 |
| −2 | K112642 | Aquilex Fluid Control System H112 | W.O.M. World of Medicine AG | 2012 | — |
| −1 | K123732 | Hysteroscopy Pump HM6 | W.O.M. World of Medicine AG | 2013 | — |
| 0 (this device) | K190372 | Aveta System | Meditrina, Inc. | 2019 | — |
| +1 | K213171 | Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta… | Meditrina, Inc. | 2022 | — |
| +2 | K223813 | Aveta System 2.0 | Meditrina, Inc. | 2023 | — |
| +1 | K192100 | Aveta Disposable Hysteroscope | Meditrina, Inc. | 2019 | — |
| +1 | K191958 | Aveta System | Meditrina, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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 HIH? 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 HIH device
- #1 K232003 Endoscopic Video Image Processor, Single-Use…score 16.1 · 12 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 |
|---|---|---|---|
| * | K152143 | TRUCLEAR Operative Hysteroscope 5C and Sheath 5CSummary page 4…(k)# Clearance Date Truclear Operative Hysteroscope 5C and K152143 September 2, 2015 Sheath 5C PREDICATE Smith & Nephew DEVICE (… | 2015 |
| * | K123732 | Hysteroscopy Pump HM6Summary page 4…Smith & Nephew DEVICE (System) (Truclear Hysteroscopic Fluid Morcellation Management System K123732 April 4, 2013 (see NOTE 1) System) (see NOTE 2) Tr… | 2013 |
| * | K132015 | Truclear Morcellation System and Truclear MorcellatorsSummary page 4…(see NOTE 2) Truclear Morcellator System and Truclear K132015 March 18, 2005 Morcellators NOTE 1: The Smith & Nephew Truclear Morcellat… | 2013 |
| † | K123151 | Endosee Model 8000 U-Scope | 2013 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 5 of the 41 ancestors have a recall of any class.
- Of its descendants, K213171 (Meditrina, Inc., 2022) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K152143.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · HIH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HIH
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HIH
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HIH
1,698in 2025
MAUDE reports naming product code HIH, 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 | 1 | — | 0 | 7 |
| 2008 | 2 | — | 0 | 12 |
| 2009 | 4 | 130 | 0 | 17 |
| 2010 | 4 | 109 | 0 | 31 |
| 2011 | 3 | 118 | 0 | 59 |
| 2012 | 4 | 25 | 0 | 78 |
| 2013 | 5 | 144 | 0 | 111 |
| 2014 | 2 | — | 0 | 125 |
| 2015 | 5 | 52 | 0 | 211 |
| 2016 | 3 | 106 | 0 | 172 |
| 2017 | 2 | — | 0 | 336 |
| 2018 | 8 | 135 | 0 | 182 |
| 2019 | 14 | 91 | 1 | 220 |
| 2020 | 7 | 88 | 0 | 253 |
| 2021 | 4 | 194 | 0 | 193 |
| 2022 | 2 | — | 0 | 289 |
| 2023 | 4 | 200 | 2 | 1,449 |
| 2024 | 6 | 148 | 0 | 1,611 |
| 2025 | 3 | 111 | 0 | 1,698 |
| 2026 | 7 | 168 | 3 | — |
What is it indicated for?
The Aveta System is intended for intrauterine use by trained gynecologists to permit viewing of the cervical canal and the uterine cavity, provide liquid distension of the uterus and monitor the volume differential between the irrigation fluid flowing into and out of the uterus during diagnostic and surgical procedures to resect and remove tissue such as submucous myomas, endometrial polyps and retained products of conception.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190372: Aveta System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190372
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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