510(k) · Cleared
ClearedHypodermic Needle-Pro EDGE Safety Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on Aug 26, 2021 as substantially equivalent to K071785 (Smiths Medical Asd, Inc., 2007) after a 91-day review. Its family tree reaches back 5 generations to 1990. 5 later devices descend from it.
- Decided
- Aug 26, 2021
- Review
- 91 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K904198 (1990). 13 ancestors in all, the oldest K771203 (1977). 5 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK904198 Safety Needle SheathConcord/Portex · 1990
- 4 generations backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
- 3 generations backK041399 Hypodermic Needle-Pro Edge Needle Protection DeviceSmiths Medical Asd, Inc. · 2004 · Recalled
- 2 generations backK061194 Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210…Smiths Medical Asd, Inc. · 2006
- 1 generation backK071785 Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge…Smiths Medical Asd, Inc. · 2007
- This deviceK211634 Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc. · 2021
- Descendant · cites it directly · 4 of its ownK232943 Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc. · 2024
- Descendant · 2 generations on · 2 of its ownK242291 SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip…Sol-Millennium Medical, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK253110 Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK260514 Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle…CMT Health PTE., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK252814 Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe…CMT Health PTE., Ltd. · 2026
Most influential descendants
Showing 5 of 5 · See all- K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc. · 2024 · cites it directly4descendants
- K242291SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead…Sol-Millennium Medical, Inc. · 2024 · 2 generations on2descendants
- K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026 · 3 generations on0descendants
- K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead…CMT Health PTE., Ltd. · 2026 · 2 generations on0descendants
- K252814Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™ Low Dead…CMT Health PTE., Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904198 | Safety Needle Sheath | Concord/Portex | 1990 | — |
| −4 | K923127 | Needle-Pro Cartridge | Concord/Portex | 1993 | 1 |
| −3 | K041399 | Hypodermic Needle-Pro Edge Needle Protection Device | Smiths Medical Asd, Inc. | 2004 | 4 |
| −2 | K061194 | Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510… | Smiths Medical Asd, Inc. | 2006 | — |
| −1 | K071785 | Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety… | Smiths Medical Asd, Inc. | 2007 | — |
| 0 (this device) | K211634 | Hypodermic Needle-Pro EDGE Safety Device | Smiths Medical Asd, Inc. | 2021 | — |
| +1 | K232943 | Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe | Smiths Medical Asd, Inc. | 2024 | — |
| +2 | K242291 | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe… | Sol-Millennium Medical, Inc. | 2024 | — |
| +3 | K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | Sol-Millennium Medical, Inc. | 2026 | — |
| +2 | K260514 | Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™… | CMT Health PTE., Ltd. | 2026 | — |
| +3 | K252814 | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe; Profoject™… | CMT Health PTE., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2026 | 3 | 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 FMI? 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? (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 |
|---|---|---|---|
| * | K071785 | Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with…Summary page 4…Name: 880.5570 (Hypodermic Single Lumen Needles) & 880.5860 (Piston Syringes) Panel: 80, General Hospital Product Code: FMI & FMF & MEG d. Predicate Device Information K071785 (Smiths Medical ASD, Inc.) Hypodermic Needle-Pro® EDGE™ Safety Device and EDGE™ Safety Device with Syringe. The Hypodermic Needle… | 2007 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232943 | Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe | 2024 | 4 |
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 31 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K232943 (Smiths Medical Asd, Inc., 2024) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K071785.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 device is intended for use to inject fluids or withdraw fluids from the body. 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/K211634 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211634: Hypodermic Needle-Pro EDGE Safety Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211634
Report an extraction error
Are you the manufacturer?
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