510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Hypodermic Needle-Pro Edge Needle Protection Device

K041399510(k) AbbreviatedCleared Jul 28, 200463-day reviewClass II21 CFR 880.5570Recalls 4

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Smiths Medical Asd, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Jul 28, 2004 as substantially equivalent to K923127 (Concord/Portex, 1993) and 1 other predicate after a 63-day review. Its family tree reaches back 2 generations to 1990. 11 later devices descend from it. It has been recalled 4 times.

Decided
Jul 28, 2004
Review
63 days
Class
Class II
Product code
FMI
Recalls
4
Predicates
2

Its longest line of descent runs back 2 generations to K904198 (1990). 3 ancestors in all. 11 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2006: 1 descendant cleared2007: 2 descendants cleared2008: 2 descendants cleared2021: 1 descendant cleared2024: 2 descendants cleared2026: 3 descendants clearedK904198 · Safety Needle Sheath · Concord/Portex · 1990K923127 · Needle-Pro Cartridge · Concord/Portex · 1993 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 2 descendants K923127 · Needle-Pro Cartridge · Concord/Portex · 1993 · recalledK904198 · Safety Needle Sheath · Concord/Portex · 19900+5
  1. Root · 2 generations backK904198 Safety Needle SheathConcord/Portex · 1990
  2. 1 generation backK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
  3. This deviceK041399 Hypodermic Needle-Pro Edge Needle Protection DeviceSmiths Medical Asd, Inc. · 2004
  4. Descendant · cites it directly · 9 of its ownK061194 Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210…Smiths Medical Asd, Inc. · 2006
  5. Descendant · cites it directly · 8 of its ownK063450 Portex Hypodermic Needle- Pro Edge Safety Device, 18GX1, 401810…Smiths Medical Asd, Inc. · 2007
  6. Descendant · cites it directly · 7 of its ownK071785 Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge…Smiths Medical Asd, Inc. · 2007
  7. Descendant · 2 generations on · 5 of its ownK211634 Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc. · 2021
  8. Descendant · 3 generations on · 4 of its ownK232943 Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc. · 2024

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2006: 12007: 22008: 22021: 12024: 22026: 3
2006high 3 (2026) · low 0 (2009)2026

Most influential descendants

Showing 5 of 11 · See all
  • K061194Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558Smiths Medical Asd, Inc. · 2006 · cites it directly9descendants
  • K063450Portex Hypodermic Needle- Pro Edge Safety Device, 18GX1, 401810, 19GX1, 401910…Smiths Medical Asd, Inc. · 2007 · cites it directly8descendants
  • K071785Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with…Smiths Medical Asd, Inc. · 2007 · cites it directly7descendants
  • K211634Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc. · 2021 · 2 generations on5descendants
  • K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc. · 2024 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K904198Safety Needle SheathConcord/Portex1990—
−1K923127Needle-Pro CartridgeConcord/Portex19931
0 (this device)K041399Hypodermic Needle-Pro Edge Needle Protection DeviceSmiths Medical Asd, Inc.2004—
+1K061194Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510…Smiths Medical Asd, Inc.2006—
+1K063450Portex Hypodermic Needle- Pro Edge Safety Device, 18GX1, 401810, 19GX1…Smiths Medical Asd, Inc.2007—
+1K071785Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety…Smiths Medical Asd, Inc.2007—
+2K211634Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc.2021—
+3K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200720
200820
202110
202420
202630
FIG. 1 — Lineage of K041399, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252886 Pen Needlescore 14.5 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K923127Needle-Pro Cartridge
Summary page 2
…needle protection PRODUCT CLASS/CLASSIFICATION: Class TI, 80 FMI, 21 CFR 880.5570 (Hypodermic Single Luinen Needles) Bivona, PREDICATE DEVICE(S): K923 127 Needle ProTM Cartridge and K9S 1254 Becton Dickinson SafetyGlideTM Needles DESCRIPTION. This device is intended for injection o…
Concord/Portex19931
*K951254Safetyglide NeedleBd Becton Dickinson Vacutainer Systems Preanalytic19954

Also cleared against K923127: 2 other devices →

What descends from it? (11)

See all 11

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061194Portex Needle-Pro Edge Safety with Syringe, Models 432310, 432210, 432510, 432558Smiths Medical Asd, Inc.20069
K063450Portex Hypodermic Needle- Pro Edge Safety Device, 18GX1, 401810, 19GX1, 401910…Smiths Medical Asd, Inc.20078
K071785Hypodermic Needle-Pro Edge Safety Device, Hypodermic Needle-Pro Edge Safety Device with…Smiths Medical Asd, Inc.20077

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 11, 2019Class IIZ-1733-2019Employee errorIncorrect needle length and gage.
Nov 21, 2014Class IIZ-0897-2015Process controlNeedle is not captured in the needle safety sheath in specific lots.
Nov 21, 2014Class IIZ-0898-2015Process controlNeedle is not captured in the needle safety sheath in specific lots.
Nov 21, 2014Class IIZ-0899-2015Process controlNeedle is not captured in the needle safety sheath in specific lots.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 11.2 years on median.
  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K061194 (Smiths Medical Asd, Inc., 2006) has gone furthest, with 9 descendants of its own.
  • 2 other devices also cite its predicate K923127.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMI

11in 2025

2007: 152008: 102009: 72010: 152011: 122012: 172013: 112014: 142015: 102016: 202017: 92018: 202019: 122020: 112021: 182022: 232023: 182024: 32025: 112026 (partial year): 12
2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007: 71 days median2008: 85 days median2009: 177 days median2010: 119 days median2011: 113 days median2012: 107 days median2013: 87 days median2014: 155 days median2015: 89 days median2016: 217 days median2017: 253 days median2018: 176 days median2019: 186 days median2020: 263 days median2021: 143 days median2022: 189 days median2023: 112 days median2024: 90 days median2025: 141 days median2026 (partial year): 119 days median
2007high 263 (2020) · low 71 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FMI

1in 2024

2007: 22008: 42009: 32010: 792011: 52012: 12013: 12014: 32015: 12017: 162019: 52020: 32021: 72023: 22024: 12026 (partial year): 1, 1 Class I
2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007: 2082008: 1772009: 2632010: 2492011: 2402012: 2152013: 2552014: 2872015: 5672016: 9412017: 1,5472018: 2,3982019: 4,8962020: 4,2452021: 4,5322022: 4,8852023: 4,9862024: 4,0532025: 2,424
2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715712208
200810854177
200971773263
20101511979249
2011121135240
2012171071215
201311871255
2014141553287
201510891567
2016202170941
20179253161,547
20182017602,398
20191218654,896
20201126334,245
20211814374,532
20222318904,885
20231811224,986
202439014,053
20251114102,424
2026121191 (1)—

What is it indicated for?

This device is intended for injection or aspiration of fluids utilizing a Luer Lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.

Indications for use as stated in the FDA summary.

Also cleared against K923127

2 other devices cite the same predicate.

  • K031453Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
  • K011925Hypodermic Needle-Pro Needle with Needle Protection Device; Hypodermic Needle-Pro Syringe & Needle with…Sims Portex, Inc. · 20011 recall

More from Smiths Medical Asd, Inc.

70 FDA decisions under this applicant name. See the company

  • K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeSmiths Medical Asd, Inc. · 2024
  • K210833Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra…Smiths Medical Asd, Inc. · 2021
  • K211634Hypodermic Needle-Pro EDGE Safety DeviceSmiths Medical Asd, Inc. · 2021
  • K192375Intellifuse Administration and Intellifuse Blood Administration SetsSmiths Medical Asd, Inc. · 2020
  • K181699Level 1 Convective WarmerSmiths Medical Asd, Inc. · 2018

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https://510kreport.com/device/K041399 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041399: Hypodermic Needle-Pro Edge Needle Protection Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041399

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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