510(k) · Cleared
ClearedAsap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap Oesophagoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Asap Endoscopic Products GmbH · FAJ Cystoscope And Accessories, Flexible/Rigid
Cleared on Jun 30, 2003 as substantially equivalent to K992983 (Innovative Endoscopy Components, LLC, 1999) and 2 other predicates after an 81-day review. Its family tree reaches back 1 generation to 1996. 21 later devices descend from it.
- Decided
- Jun 30, 2003
- Review
- 81 days
- Class
- Class II
- Product code
- FAJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K963426 (1996). 3 ancestors in all. 21 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK963426 Karl Storz Contact Micro-LaryngoscopesKARL STORZ Endoscopy-America, Inc. · 1996
- This deviceK031141 Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap…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 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · 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 |
|---|---|---|---|---|---|
| −1 | K963426 | Karl Storz Contact Micro-Laryngoscopes | KARL STORZ Endoscopy-America, Inc. | 1996 | — |
| 0 (this device) | K031141 | Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap Oesophagoscope | 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 |
|---|---|---|
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 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 FAJ? 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 FAJ device
- #1 K193095 Ambu aScope 4 Cystoscore 31.5 · 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? (4)
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 |
|---|---|---|---|
| * | K992983 | Baho Autoclavable CystoscopeSummary page 1…) Laryngoscope, Types: 10-0062-00, 10-0048-00 d) Oesophagoscope, Type: 10-0049-00 Common name Endoscope Predicate device name - Cystoscope: Baho Cystoscope (K992983) - Laparoscope: AED Laparoscope (K993688) - Laryngoscope: Karl Storz Laryngoscope (K963426) - Oesophagoscope: Baho Esophagoscope… | 1999 |
| * | K993688 | Aed LaparoscopeSummary page 1…10-0048-00 d) Oesophagoscope, Type: 10-0049-00 Common name Endoscope Predicate device name - Cystoscope: Baho Cystoscope (K992983) - Laparoscope: AED Laparoscope (K993688) - Laryngoscope: Karl Storz Laryngoscope (K963426) - Oesophagoscope: Baho Esophagoscope Code of Federal Regulations (CFR) number… | 1999 |
| * | K963426 | Karl Storz Contact Micro-LaryngoscopesSummary page 1…0 Common name Endoscope Predicate device name - Cystoscope: Baho Cystoscope (K992983) - Laparoscope: AED Laparoscope (K993688) - Laryngoscope: Karl Storz Laryngoscope (K963426) - Oesophagoscope: Baho Esophagoscope Code of Federal Regulations (CFR) number 876.1500 General device description The asap end… | 1996 |
| * | — | Baho Esophagoscope Named without a submission number |
What descends from it? (21)
See all 212 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K060899 (Schoelly Imaging, Inc., 2007) has gone furthest, with 19 descendants of its own.
How does its category compare?
All FAJ devicesFAJ Cystoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAJ
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FAJ
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FAJ
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAJ
2,690in 2025
MAUDE reports naming product code FAJ, 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 | 2 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 2 | — | 0 | 10 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 28 |
| 2016 | 1 | — | 0 | 75 |
| 2017 | 2 | — | 1 | 79 |
| 2018 | 2 | — | 0 | 79 |
| 2019 | 3 | 207 | 0 | 102 |
| 2020 | 2 | — | 0 | 339 |
| 2021 | 3 | 127 | 0 | 494 |
| 2022 | 5 | 170 | 1 | 744 |
| 2023 | 5 | 207 | 7 | 920 |
| 2024 | 9 | 130 | 0 | 892 |
| 2025 | 8 | 98 | 0 | 2,690 |
| 2026 | 5 | 123 | 0 | — |
What is it indicated for?
Like the predicate devices, the asap endoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031141: Asap Cystoscope; Asap Laparoscope; Asap Larygoscope; Asap Oesophagoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031141
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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