510(k) · Cleared
ClearedAsap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asap Endoscopic Products GmbH · HIH Hysteroscope (And Accessories)
Cleared on Sep 29, 2003 as substantially equivalent to K962256 (Galileo Electro-Optics Corp., 1996) and 1 other predicate after a 95-day review. Its family tree reaches back 2 generations to 1977. 20 later devices descend from it.
- Decided
- Sep 29, 2003
- Review
- 95 days
- Class
- Class II
- Product code
- HIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K770378 (1977). 5 ancestors in all. 20 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK770378 Laparoscope, Fiber Light, Palmer-JacobsRichard Wolf Medical Instruments Corp. · 1977
- 1 generation backK962256 Galileo Hysteroscopes and LaparoscopesGalileo Electro-Optics Corp. · 1996
- This deviceK031974 Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00…Asap Endoscopic Products GmbH · 2003
- Descendant · cites it directly · 19 of its ownK060899 Flexilux II Cystoscope and HysteroscopeSchoelly Imaging, Inc. · 2007
- Descendant · 2 generations on · 18 of its ownK150158 Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH · 2015 · Recalled
- Descendant · 3 generations on · 7 of its ownK161110 ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016
- Descendant · 3 generations on · 5 of its ownK170660 Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017
- Descendant · 4 generations on · 4 of its ownK183020 Endosee SystemCooperSurgical, Inc. · 2019 · Recalled
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K060899Flexilux II Cystoscope and HysteroscopeSchoelly Imaging, Inc. · 2007 · cites it directly19descendants
- K150158Schoelly Cystoscopes/Hysteroscopes and AccessoriesSchoelly Fiberoptic GmbH · 2015 · 2 generations on18descendants
- K161110ClearPetra Suction-Evacuation SheathWell Lead Medical Co., Ltd. · 2016 · 3 generations on7descendants
- K170660Endosee Hysteroscope with Disposable Diagnostic (Dx) CannulaCooperSurgical, Inc. · 2017 · 3 generations on5descendants
- K183020Endosee SystemCooperSurgical, Inc. · 2019 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K770378 | Laparoscope, Fiber Light, Palmer-Jacobs | Richard Wolf Medical Instruments Corp. | 1977 | — |
| −1 | K962256 | Galileo Hysteroscopes and Laparoscopes | Galileo Electro-Optics Corp. | 1996 | — |
| 0 (this device) | K031974 | Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00… | Asap Endoscopic Products GmbH | 2003 | — |
| +1 | K060899 | Flexilux II Cystoscope and Hysteroscope | Schoelly Imaging, Inc. | 2007 | — |
| +2 | K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | Schoelly Fiberoptic GmbH | 2015 | 1 |
| +3 | K161110 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | 2016 | — |
| +3 | K170660 | Endosee Hysteroscope with Disposable Diagnostic (Dx) Cannula | CooperSurgical, Inc. | 2017 | — |
| +4 | K183020 | Endosee System | CooperSurgical, Inc. | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K962256 | Galileo Hysteroscopes and LaparoscopesSummary page 1…10-0015-00, 10-0016-00, 10-0089-00, Common name Hysteroscope, Gyn. Laparoscope Predicate device name - Baho Hysteroscope (K # not available) and Galileo hysteroscope (K962256) - Baho Gyn. Laparoscope (K982276) Code of Federal Regulations (CFR) number 888.1690 and 884.1 720 General device description Th… | 1996 |
| * | K982276 | Baho Autoclavable LaparoscopeSummary page 1…0, Common name Hysteroscope, Gyn. Laparoscope Predicate device name - Baho Hysteroscope (K # not available) and Galileo hysteroscope (K962256) - Baho Gyn. Laparoscope (K982276) Code of Federal Regulations (CFR) number 888.1690 and 884.1 720 General device description The asap hysteroscope and gynecologi… | 1999 |
| * | — | Baho Hysteroscope Named without a submission number |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060899 | Flexilux II Cystoscope and Hysteroscope | 2007 | 19 |
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 26 years and passes through 3 companies; a new generation was cleared every 19.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K060899 (Schoelly Imaging, Inc., 2007) has gone furthest, with 19 descendants of its own.
How does its category compare?
All HIH devicesHIH Hysteroscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Hysteroscope: Provides illumination and visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Gynecologic Laparoscope: Used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031974 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031974: Asap Hysteroscope and Gynecologic Laparoscope (Surgery) 10-00018-00, 10-0019-00, 100020-00, 10-0021-00, 10-0022-00, 10-0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031974
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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