510(k) · Cleared
ClearedItalite , Model 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jg Medical Products, LLC · HRX Arthroscope
Cleared on Dec 7, 2007 as substantially equivalent to K894303 (Medscope Corp., 1989) and 1 other predicate after a 338-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Dec 7, 2007
- Review
- 338 days
- Class
- Class II
- Product code
- HRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K962330 (1996). 3 ancestors in all, the oldest K894303 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK962330 Amo ArthoscopesAmerican Microptiks, Inc. · 1996
- 1 generation backK031972 Asap Arthroscope Models; 10-0001-00, 10-0002-00, 10-0003-00…Asap Endoscopic Products GmbH · 2003
- This deviceK070021 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 · cites it directly · 0 of its ownK163037 Intra medullary endo-transilluminating device (iMET device)WeMED Bio-Tech, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K163037Intra medullary endo-transilluminating device (iMET device)WeMED Bio-Tech, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | 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 | — |
| 0 (this device) | 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 | — |
| +1 | K163037 | Intra medullary endo-transilluminating device (iMET device) | WeMED Bio-Tech, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K894303 | Medscope 4MM ArthroscopeSummary page 2…devices: Trade or Proprietary Name Manufacturer 510(k) Number Medscope 4mm Arthroscope Medscope Corp. k894303 ASAP Arthroscope ASAP Endoscopic Products k031972 All of the above predicate Arthroscopes have… | 1989 |
| * | K031972 | Asap Arthroscope Models; 10-0001-00, 10-0002-00, 10-0003-00, 10-0004-00, 10-0005-00…Summary page 2…510(k) Number Medscope 4mm Arthroscope Medscope Corp. k894303 ASAP Arthroscope ASAP Endoscopic Products k031972 All of the above predicate Arthroscopes have two fiber optic channels, one for viewing and one for illuminating the subject fie… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163037 | Intra medullary endo-transilluminating device (iMET device) | 2017 | 0 |
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 11 years and passes through 3 companies; a new generation was cleared every 7.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K163037 (WeMED Bio-Tech, Inc., 2017) has gone furthest, with 0 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. 2007, this device’s year, is highlighted.
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?
The ITALITE Light Wand is indicated for illumination during joint examinations, arthroscopies, biopsies, in minimally invasive procedures of the knee, shoulder, temporal-mandibular joint, ankle, and elbow.
The ITALITE Light Wand is disposable, single use and is intended to be discarded after the procedure. It is supplied clean but not sterile and must be sterilized before use.
The ITALITE is for illumination only and is not indicated for viewing. It is to be used by physicians only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070021: Italite , Model 500-3.1, 550-3.1, 600-3.1, 650-3.1, 450-2.0,400-2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070021
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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