510(k) · Cleared
Recalled · Class II · 2018Arrow Echogenic Introducer Needle Component
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Sep 26, 2007 as substantially equivalent to K040100 (Arrow Intl., Inc., 2004) and 3 other predicates after a 65-day review. Its family tree reaches back 2 generations to 1981. 3 of the 7 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times.
- Decided
- Sep 26, 2007
- Review
- 65 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 2 generations to K810675 (1981). 6 ancestors in all. No later device cites it as a predicate yet. 3 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK810675 Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · Recalled (Class I)
- 1 generation backK021120 Radial Artery Catherization Set with Integral Needle…Arrow Intl., Inc. · 2002 · Recalled (Class I)
- This deviceK071998 Arrow Echogenic Introducer Needle ComponentArrow Intl., Inc. · 2007
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810675 | Arrow Radial Artery Catheterization Set | Arrow Intl., Inc. | 1981 | Class I |
| −1 | K021120 | Radial Artery Catherization Set with Integral Needle Protection,Model… | Arrow Intl., Inc. | 2002 | Class I |
| 0 (this device) | K071998 | Arrow Echogenic Introducer Needle Component | Arrow Intl., Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2000 | 1 | 1 |
| 2004 | 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.
3 devices in this family have a Class I recall. 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 4 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 |
|---|---|---|---|
| * | K040100 | Arrow Echogenic Introducer NeedleSummary page 1…Hypodermic single lumen needle; Product Code FMI; 21 CFR 880.5570, Class II Le~gally marketed devices to Arrow Echogenic Needle (K040100, SE date 3/1/2004) which the device is Arrow Extended Vascular Access Needle (K924338, SE Substantially equivalent:… | 2004 |
| * | K924338 | Arrow-Fischell Extended Vascular Access NeedleSummary page 1…570, Class II Le~gally marketed devices to Arrow Echogenic Needle (K040100, SE date 3/1/2004) which the device is Arrow Extended Vascular Access Needle (K924338, SE Substantially equivalent: date 3/1 8/1 993) Radial Artery Catheterization Set with in… | 1993 |
| * | K021120 | Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SPSummary page 1…equivalent: date 3/1 8/1 993) Radial Artery Catheterization Set with integral needle protection (K021120, SE date: 5/2/2002) PICC Two-Lumen Peripherally Inserted Central Catheter… | 2002 |
| * | K003006 | Two-Lumen Picc with Blue Flextip Catheter and Integral Needle ProtectionSummary page 1…Peripherally Inserted Central Catheter Kit with Blue FlexTip® Catheter and Integral Needle Protection (K003006, SE date: 10/27/2000) Description of the device: The Arrow Echogenic Introducer Needle has the following… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 11, 2018 | Class II | Z-2022-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1959-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K021120Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SPArrow Intl., Inc. · 2002 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K003006Two-Lumen Picc with Blue Flextip Catheter and Integral Needle ProtectionArrow Intl., Inc. · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 1 company; a new generation was cleared every 21.1 years on median.
- 4 of the 6 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The Arrow Echogenic Introducer Needle allows access to the vascular system for the introduction of a guidewire to facilitate catheter placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071998 · printed Nov 3, 2026
Cite this page
510(k) Report. “K071998: Arrow Echogenic Introducer Needle Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K071998
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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