510(k) · Cleared
ClearedAlphahysteroscope, Fiberoptic, Operative and Diagnostic
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gimmi GmbH · HIH Hysteroscope (And Accessories)
Cleared on Feb 12, 2010 as substantially equivalent to K972426 (Imagyn Medical, Inc., 1997) and 1 other predicate after a 189-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Feb 12, 2010
- Review
- 189 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972426 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK972426 Microspan Gold Hysteroscope and Microspan Hysteroscope SheathImagyn Medical, Inc. · 1997
- This deviceK092421 Alphahysteroscope, Fiberoptic, Operative and DiagnosticGimmi GmbH · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972426 | Microspan Gold Hysteroscope and Microspan Hysteroscope Sheath | Imagyn Medical, Inc. | 1997 | — |
| 0 (this device) | K092421 | Alphahysteroscope, Fiberoptic, Operative and Diagnostic | Gimmi GmbH | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972426 | Microspan Gold Hysteroscope and Microspan Hysteroscope SheathSummary page 7…The AlphaScope Hysteroscope is substantially equivalent to the following predicate devices: MicroSpan Gold Hysteroscope (K972426) Alpha Hysteroscope, Rod Lenses (KO 12869) Classification: 21 CFR § 884.1690 Product code 85 HIH… | 1997 |
| * | K012869 | Gimmi Alpha Hysteroscopes & Accessories, Models E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX…Summary page 2…(807.92) AlphaScope Hysteroscop has the same intended use as the predicate devices. It is made of the same materials as one of the predicate device (Alpha Hysteroscope, K012869) and is produced to the same international and FDA-recognized standards. Slight modifications in design, diameter and material do… | 2002 |
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.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
AlphaScope Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
AlphaScope Hysteroscope is used with Hysteroscope Sheaths to provide access to the uterine cavity during diagnostic and operative hysteroscopic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092421: Alphahysteroscope, Fiberoptic, Operative and Diagnostic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092421
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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