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 Feb 8, 2008 as substantially equivalent to K071785 (Smiths Medical Asd, Inc., 2007) and 1 other predicate after an 87-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Feb 8, 2008
- Review
- 87 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K904198 (1990). 14 ancestors in all, the oldest K771203 (1977). No later device cites it as a predicate yet.
- 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 deviceK073188 Hypodermic Needle-Pro Edge Safety DeviceSmiths Medical Asd, Inc. · 2008
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) | K073188 | Hypodermic Needle-Pro Edge Safety Device | Smiths Medical Asd, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 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 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? (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 |
|---|---|---|---|
| * | K071785 | Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with…Summary page 1…es (21 CFR 880.5570, Product Code FMI). Accessory to Tubes, Vials, Systems, Serum Separators, Blood Collection (21 CFR 862.1675, Product Code JKA). Predicate Device(s): K071785 (Smiths Medical ASD, bec.) Hypodermic Needle-Proo EDGEm Safety Device and EDGETM Safety Device with Syringe K91 1037 (Smiths Medi… | 2007 |
| * | K911037 | Safety Needle Sheath, ModificationSummary page 1…FR 862.1675, Product Code JKA). Predicate Device(s): K071785 (Smiths Medical ASD, bec.) Hypodermic Needle-Proo EDGEm Safety Device and EDGETM Safety Device with Syringe K91 1037 (Smiths Medical ASD, Inc.- formerly Concord/Portex) Safety Needle Sheath (modification) Device Description: This device is inten… | 1991 |
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 18 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 14 ancestors have a recall of any class.
- 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. 2008, 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?
This device is intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks. The EDGE safety device may be removed from the syringe when required by a specific medical procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073188 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073188: 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/K073188
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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