510(k) · Cleared
Recalled · Class II · 2017Needle-Pro Cartridge
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Concord/Portex · FMI Needle, Hypodermic, Single Lumen
Cleared on Apr 29, 1993 as substantially equivalent to K904198 (Concord/Portex, 1990) after a 307-day review. Its family tree reaches back 1 generation to 1990. 1 of the 86 devices in its family, counting itself, has a Class I recall. 84 later devices descend from it. It has been recalled once.
- Decided
- Apr 29, 1993
- Review
- 307 days
- Class
- Class II
- Product code
- FMI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K904198 (1990). 84 later devices descend from it, 3 citing it directly. 1 of the 86 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK904198 Safety Needle SheathConcord/Portex · 1990
- This deviceK923127 Needle-Pro CartridgeConcord/Portex · 1993
- Descendant · cites it directly · 74 of its ownK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
- Descendant · 2 generations on · 67 of its ownK040531 Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004
- Descendant · 2 generations on · 65 of its ownK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005
- Descendant · 3 generations on · 60 of its ownK113422 Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe…Terumo (Philippines) Corporation · 2012
- Descendant · 4 generations on · 32 of its ownK170651 Sterile Disposable Syringe with Safety Needle, Sterile Disposable…Yangzhou Medline Industry, Co., Ltd. · 2017
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K063755 Portex Hypodermic Needle-Pro Fixed Needle Syringe3 generations on · 2007
Most influential descendants
Showing 5 of 84 · See all- K031453Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003 · cites it directly74descendants
- K040531Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004 · 2 generations on67descendants
- K051865Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005 · 2 generations on65descendants
- K113422Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety NeedleTerumo (Philippines) Corporation · 2012 · 3 generations on60descendants
- K170651Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle…Yangzhou Medline Industry, Co., Ltd. · 2017 · 4 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| 0 (this device) | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | — |
| +1 | K031453 | Terumo Surguard 2 Safety Needle | Terumo Medical Corp. | 2003 | — |
| +2 | K040531 | Terumo SURGUARD2 Safety Needle | Terumo Medical Corp. | 2004 | — |
| +2 | K051865 | Terumo Surguard 2 Safety Needle or Similar | Terumo Medical Corp. | 2005 | — |
| +3 | K113422 | Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with… | Terumo (Philippines) Corporation | 2012 | — |
| +4 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with… | Yangzhou Medline Industry, Co., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 1 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 7 | 0 |
| 2022 | 19 | 0 |
| 2023 | 7 | 0 |
| 2024 | 8 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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.
1 device in this family has 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K854597 | FDA’s K854597 is Vickers Medical Model 271 Heart Rate Monitor Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1986 |
| * | K904198 | Safety Needle SheathSummary page 1…le Pro™ are commercially available now and both have approved 510Ks. The needles are approved with 510K number K8545%7A and the Needle Pro™ is approved under 510K number K 904198. These products are safe and effective as approved. This application was to allow the two parts to be sold as a unit as Concord/P… | 1990 |
What descends from it? (84)
See all 843 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 4, 2017 | Class II | Z-2670-2017 | Process control | Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smiths Medical incoming inspection. The… |
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.
- K063755Portex Hypodermic Needle-Pro Fixed Needle SyringeSmiths Medical Asd, Inc. · 2007 · 3 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
To inject into or withdraw fluids from, parts of the body below the surface of the skin.
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/K923127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923127: Needle-Pro Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923127
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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