510(k) · Cleared
ClearedHypodermic Needle-Pro Insulin Syrine & Needle with Needle Protection Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Portex, Inc. · FMF Syringe, Piston
Cleared on Feb 13, 2002 as substantially equivalent to K011925 (Sims Portex, Inc., 2001) after a 65-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Feb 13, 2002
- Review
- 65 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K904198 (1990). No later device cites it as a predicate yet.
- Root · 3 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 2 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 1 generation backK011925 Hypodermic Needle-Pro Needle with Needle Protection Device…Sims Portex, Inc. · 2001 · Recalled
- This deviceK014073 Hypodermic Needle-Pro Insulin Syrine & Needle with Needle Protection…Portex, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −2 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| −1 | K011925 | Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic… | Sims Portex, Inc. | 2001 | 1 |
| 0 (this device) | K014073 | Hypodermic Needle-Pro Insulin Syrine & Needle with Needle Protection Device | Portex, Inc. | 2002 | — |
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 FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K011925 | Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro…Summary page 2…CLASS/CLASSIFICATION: Class II, 80 FMF, 21 CFR 880.5860 (Piston Syringe) 21 smtths Smiths Medical - a part of Smiths Group plc PREDICATE DEVICE(S): K011925 Hypodermic Needle-Pro® Syringe & Needle with Needle Protection Device DESCRIPTION: This device is intended for injection of ins… | 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 12 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K011925.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
This device is intended for injection of insulin. The needle protection device covers the needle after use to help prevent needle sticks.
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/K014073 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014073: Hypodermic Needle-Pro Insulin Syrine & Needle with Needle Protection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014073
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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