510(k) · Cleared
ClearedAmo Arthoscopes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Microptiks, Inc. · HRX Arthroscope
Cleared on Sep 11, 1996 after an 86-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Sep 11, 1996
- Review
- 86 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK962330 Amo ArthoscopesAmerican Microptiks, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK031972 Asap Arthroscope Models; 10-0001-00, 10-0002-00, 10-0003-00…Asap Endoscopic Products GmbH · 2003
- Descendant · 2 generations on · 1 of its ownK070021 Italite , Model 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0Jg Medical Products, LLC · 2007
- Descendant · 3 generations on · 0 of its ownK163037 Intra medullary endo-transilluminating device (iMET device)WeMED Bio-Tech, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See all- K031972Asap Arthroscope Models; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00…Asap Endoscopic Products GmbH · 2003 · cites it directly2descendants
- K070021Italite , Model 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0Jg Medical Products, LLC · 2007 · 2 generations on1descendant
- K163037Intra medullary endo-transilluminating device (iMET device)WeMED Bio-Tech, Inc. · 2017 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962330 | Amo Arthoscopes | American Microptiks, Inc. | 1996 | — |
| +1 | K031972 | Asap Arthroscope Models; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00… | Asap Endoscopic Products GmbH | 2003 | — |
| +2 | K070021 | Italite , Model 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0 | Jg Medical Products, LLC | 2007 | — |
| +3 | K163037 | Intra medullary endo-transilluminating device (iMET device) | WeMED Bio-Tech, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2017 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | — | Storz (Karl Storz) 7200BW Arthroscope Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031972 | Asap Arthroscope Models; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00… | 2003 | 2 |
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?
- Of its descendants, K031972 (Asap Endoscopic Products GmbH, 2003) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
Like other legally marketed arthroscopes, the AMO Arthroscope is indicated for use in minimally invasive procedures of the knee, shoulder and ankle joints, for joint examination, biopsy, arthroscopy, diagnosis of joint disease.
The device provides a clear view of the joint structures such as femoral condyles, medial meniscus, cruciate ligament, and other anatomical structures.
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/K962330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962330: Amo Arthoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962330
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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