510(k) · Cleared
ClearedFrontline Medical Safetynet Guidewire Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Injectimed, Inc. · MDM Instrument, Manual, Surgical, General Use
Cleared on Aug 8, 2008 as substantially equivalent to K040029 (Injectimed, Inc., 2004) and 1 other predicate after a 226-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Aug 8, 2008
- Review
- 226 days
- Class
- Class I
- Product code
- MDM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K971165 (1997). 9 ancestors in all, the oldest K843719 (1984). No later device cites it as a predicate yet.
- Root · 4 generations backK971165 Introducer Sheath and DilatorBoston Scientific Corp · 1997
- 3 generations backK020563 Medamicus Axia RSNMedamicus, Inc. · 2002
- 2 generations backK022689 Modification to Medamicus Axia RSNMedamicus, Inc. · 2002
- 1 generation backK040029 Safetynet Guidewire IntroducerInjectimed, Inc. · 2004
- This deviceK073664 Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971165 | Introducer Sheath and Dilator | Boston Scientific Corp | 1997 | — |
| −3 | K020563 | Medamicus Axia RSN | Medamicus, Inc. | 2002 | — |
| −2 | K022689 | Modification to Medamicus Axia RSN | Medamicus, Inc. | 2002 | — |
| −1 | K040029 | Safetynet Guidewire Introducer | Injectimed, Inc. | 2004 | — |
| 0 (this device) | K073664 | Frontline Medical Safetynet Guidewire Introducer | Injectimed, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K040029 | Safetynet Guidewire IntroducerSummary page 1…Manual surgical instrument for general use 21 CFR Sec. 878.4800 Predicate devices: SafetyNET Guidewire Introducer (K040029) Light Saber Introducer Needle (KO13040) Description of the device: A needle and h… | 2004 |
| * | K013040 | Light Saber Introducer Needle | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 4.3 years on median.
- None of the 9 ancestors has a recall.
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. 2008, this device’s year, is highlighted.
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?
A percutaneous guide wire introducer for vascular and non-vascular procedures with activating safety shield to reduce needle stick injury during use and disposal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073664 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073664: Frontline Medical Safetynet Guidewire Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073664
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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