510(k) · Cleared
ClearedLight Saber Introducer Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minrad, Inc. · MDM Instrument, Manual, Surgical, General Use
Cleared on Dec 7, 2001 after an 88-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Dec 7, 2001
- Review
- 88 days
- Class
- Class I
- Product code
- MDM
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK013040 Light Saber Introducer NeedleMinrad, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK103200 Propep Delivery DeviceRhythmlink International, LLC · 2011
- Descendant · cites it directly · 0 of its ownK073664 Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013040 | Light Saber Introducer Needle | Minrad, Inc. | 2001 | — |
| +1 | K103200 | Propep Delivery Device | Rhythmlink International, LLC | 2011 | — |
| +1 | K073664 | Frontline Medical Safetynet Guidewire Introducer | Injectimed, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 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 MDM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | — | Introducer Needle Accessory, Oratec Interventions, Inc. Named without a submission number | |
| * | — | Light Saber™ Aspiration Needle, MINRAD, Inc. Named without a submission number |
What descends from it? (2)
2 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?
- Of its descendants, K103200 (Rhythmlink International, LLC, 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MDM devicesMDM Instrument, Manual, Surgical, General Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MDM
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · MDM
Too few MDM 510(k)s in any year since 2007 to give a median.
Recalls per year · MDM
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MDM
318in 2025
MAUDE reports naming product code MDM, 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 | 0 | — | 0 | 25 |
| 2008 | 1 | — | 0 | 50 |
| 2009 | 0 | — | 1 | 131 |
| 2010 | 0 | — | 17 | 49 |
| 2011 | 0 | — | 1 | 52 |
| 2012 | 0 | — | 0 | 53 |
| 2013 | 0 | — | 0 | 74 |
| 2014 | 0 | — | 1 | 66 |
| 2015 | 0 | — | 0 | 161 |
| 2016 | 0 | — | 0 | 317 |
| 2017 | 0 | — | 2 | 187 |
| 2018 | 0 | — | 0 | 400 |
| 2019 | 0 | — | 0 | 281 |
| 2020 | 0 | — | 0 | 245 |
| 2021 | 0 | — | 1 | 227 |
| 2022 | 0 | — | 2 | 182 |
| 2023 | 0 | — | 0 | 209 |
| 2024 | 0 | — | 1 | 507 |
| 2025 | 0 | — | 0 | 318 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
For use with the Dual Radiation Targeting System (ie: DRTS) to improve the accuracy of the needle placement.
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/K013040 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013040: Light Saber Introducer Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013040
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026