510(k) Report

510(k) · Cleared

Cleared

Safety Needle Sheath

K904198510(k) TraditionalCleared Dec 19, 199098-day reviewClass II21 CFR 880.5570

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

Concord/Portex · FMI Needle, Hypodermic, Single Lumen

Cleared on Dec 19, 1990 after a 98-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 87 devices in its family, counting itself, has a Class I recall. 86 later devices descend from it.

Decided
Dec 19, 1990
Review
98 days
Class
Class II
Product code
FMI
Recalls
None
Predicates
0

86 later devices descend from it, 2 citing it directly. 1 of the 87 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2002: 2 descendants cleared1993: 1 descendant cleared2001: 1 descendant cleared2003: 2 descendants cleared2004: 2 descendants cleared2005: 1 descendant cleared2007: 4 descendants cleared, 1 with a Class I recall12006: 1 descendant cleared2009: 1 descendant cleared2011: 2 descendants cleared2012: 2 descendants cleared2019: 2 descendants cleared2008: 2 descendants cleared2021: 7 descendants cleared2010: 1 descendant cleared2026: 6 descendants cleared2017: 1 descendant cleared2022: 19 descendants cleared2015: 2 descendants cleared2018: 1 descendant cleared2013: 1 descendant cleared2024: 8 descendants cleared2025: 6 descendants cleared2020: 4 descendants cleared2023: 7 descendants cleared1990200020102020
  1. This deviceK904198 Safety Needle SheathConcord/Portex · 1990
  2. Descendant · cites it directly · 84 of its ownK923127 Needle-Pro CartridgeConcord/Portex · 1993 · Recalled
  3. Descendant · 2 generations on · 74 of its ownK031453 Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003
  4. Descendant · 3 generations on · 67 of its ownK040531 Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004
  5. Descendant · 3 generations on · 65 of its ownK051865 Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005
  6. Descendant · 4 generations on · 60 of its ownK113422 Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe…Terumo (Philippines) Corporation · 2012

Showing 5 of 86 descendants. See all descendants

Descendants cleared per year

1993: 12001: 12002: 22003: 22004: 22005: 12006: 12007: 42008: 22009: 12010: 12011: 22012: 22013: 12015: 22017: 12018: 12019: 22020: 42021: 72022: 192023: 72024: 82025: 62026: 6
1993high 19 (2022) · low 0 (1994)2026

Class I recalls in this family

  • K063755 Portex Hypodermic Needle-Pro Fixed Needle Syringe4 generations on · 2007

Most influential descendants

Showing 5 of 86 · See all
  • K923127Needle-Pro CartridgeConcord/Portex · 1993 · cites it directly84descendants
  • K031453Terumo Surguard 2 Safety NeedleTerumo Medical Corp. · 2003 · 2 generations on74descendants
  • K040531Terumo SURGUARD2 Safety NeedleTerumo Medical Corp. · 2004 · 3 generations on67descendants
  • K051865Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp. · 2005 · 3 generations on65descendants
  • K113422Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with Safety NeedleTerumo (Philippines) Corporation · 2012 · 4 generations on60descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904198Safety Needle SheathConcord/Portex1990—
+1K923127Needle-Pro CartridgeConcord/Portex19931
+2K031453Terumo Surguard 2 Safety NeedleTerumo Medical Corp.2003—
+3K040531Terumo SURGUARD2 Safety NeedleTerumo Medical Corp.2004—
+3K051865Terumo Surguard 2 Safety Needle or SimilarTerumo Medical Corp.2005—
+4K113422Terumo Surguard 3 Safety Needle Terumo Surguard 3 Hypodermic Syringe with…Terumo (Philippines) Corporation2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199310
200110
200220
200320
200420
200510
200610
200741
200820
200910
201010
201120
201220
201310
201520
201710
201810
201920
202040
202170
2022190
202370
202480
202560
202660
FIG. 1 — Lineage of K904198, 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), 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. #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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (86)

See all 86

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

NumberDeviceApplicantDecidedDescendants
K923127Needle-Pro CartridgeConcord/Portex199384
K013006Ovus Capless Safety NeedleOvus Systems20020

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

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 · 4 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K923127 (Concord/Portex, 1993) has gone furthest, with 84 descendants of its own.

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)—

More from Concord/Portex

23 FDA decisions under this applicant name. See the company

  • K923559Steri-Cath MdiConcord/Portex · 1993
  • K930218Subcutaneous Tunneling Needle and HandlesConcord/Portex · 1993
  • K924541Epidural MinipackConcord/Portex · 1993
  • K930286Dri-Vendt/Provent/Accuvent Arterial Blood Gas KitsConcord/Portex · 1993
  • K923127Needle-Pro CartridgeConcord/Portex · 19931 recall

Recent decisions in FMI

The FMI category page

  • K261266MOWANA™ Auto DuoPentamaster Mediq SDN BHD · 2026
  • K261719Promisemed X-Safety Pen NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2026
  • K262427Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety…Hh Global Technology, Inc. · 2026
  • K260933Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R, NR-S2016R, NR-S2025R…Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · 2026
  • K261829Profoject™ Dual-Safety Pen NeedlesCMT Health PTE., Ltd. · 2026

https://510kreport.com/device/K904198 · printed Nov 6, 2026

Cite this page

510(k) Report. “K904198: Safety Needle Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904198

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026